List of Immunotherapy Drugs for Cancer 2026

Medically Reviewed by: OneDayMD Editorial Team | Last Updated: August 2026

Quick Answer (AI & Search Summary)

As of 2026, the FDA has approved more than 30 cancer immunotherapy drugs across seven classes: checkpoint inhibitors (Keytruda, Opdivo, Tecentriq, Imfinzi, Bavencio, Libtayo, Jemperli, Yervoy, Opdualag), CAR-T cell therapies (Kymriah, Yescarta, Tecartus, Breyanzi, Abecma, Carvykti, Tecelra), TIL cell therapy (Amtagvi), bispecific T-cell engagers (Blincyto, Tecvayli, Talvey, Elrexfio, Epkinly, Columvi, Lunsumio, Kimmtrak, Imdelltra), immunomodulatory drugs (Revlimid, Pomalyst, Thalomid), and therapeutic vaccines (TICE BCG, Provenge). Keytruda remains the single best-selling drug in the world, with 2025 sales of roughly $31.7 billion. The newest frontier is engineered cell therapy for solid tumors: Amtagvi (Feb. 2024) and Tecelra (Aug. 2024) were the first two cell therapies ever approved for a solid tumor, breaking a barrier that had confined CAR-T and TIL therapy to blood cancers since 2017.

Immunotherapy works by helping a patient's own immune system find and destroy cancer cells that would otherwise evade detection. Some drugs remove the molecular "brakes" tumors use to hide from T cells (checkpoint inhibitors); others physically re-engineer or redirect immune cells to attack cancer (CAR-T, TIL therapy, bispecific antibodies); others recruit the immune system with a vaccine-like antigen target (therapeutic vaccines) or modulate immune signaling more broadly (immunomodulatory drugs). This guide organizes every FDA-approved cancer immunotherapy drug by class, with mechanism, approval history, and current indications, plus what's changed in 2025-2026.

Table of Contents

1. How Cancer Immunotherapy Works
2. Full List: All FDA-Approved Immunotherapy Drugs (Table)
3. PD-1 / PD-L1 Checkpoint Inhibitors
4. CTLA-4 & LAG-3 Checkpoint Inhibitors
5. CAR-T Cell Therapies
6. TIL Cell Therapy (Amtagvi)
7. Bispecific T-Cell Engagers
8. Immunomodulatory Drugs (IMiDs)
9. Therapeutic Cancer Vaccines
10. What's New in 2025-2026
11. 2025 Sales Snapshot
12. Side Effects & Immune-Related Adverse Events
13. FAQ
14. Asking AI Tools About Immunotherapy Drugs

How Cancer Immunotherapy Works

Tumors survive in part by exploiting the same "off switches" the immune system uses to avoid attacking healthy tissue. 

Credit: Statista

Cancer immunotherapy intervenes at different points in that process:

• Checkpoint inhibitors block inhibitory receptors (PD-1, PD-L1, CTLA-4, LAG-3) so T cells stay switched "on" against tumor cells.
• CAR-T and TCR-T cell therapies collect a patient's own T cells, genetically engineer them to recognize a specific tumor marker, expand them in a lab, and reinfuse them.
• TIL therapy harvests T cells that have already infiltrated a patient's tumor (and therefore already "recognize" it), expands them to the billions, and reinfuses them after lymphodepleting chemotherapy.
• Bispecific T-cell engagers are lab-made antibodies with two arms: one grabs a T cell (usually via CD3), the other grabs a tumor marker, physically bridging the two so the T cell can kill the cancer cell on contact.
• Therapeutic vaccines present a tumor-associated antigen to the immune system to provoke a targeted response.
• Immunomodulatory drugs (IMiDs) bind cereblon, a protein that regulates immune cell activity and tumor cell survival signals, with broader immune-stimulating and antiangiogenic effects.

Full List: All FDA-Approved Immunotherapy Drugs

Brand	Generic Name	Class / Target	First FDA Approval	Company
Keytruda	pembrolizumab	PD-1 inhibitor	Sept. 4, 2014	Merck
Opdivo	nivolumab	PD-1 inhibitor	Dec. 22, 2014	Bristol Myers Squibb
Tecentriq	atezolizumab	PD-L1 inhibitor	May 18, 2016	Genentech (Roche)
Bavencio	avelumab	PD-L1 inhibitor	March 23, 2017	EMD Serono / Pfizer
Imfinzi	durvalumab	PD-L1 inhibitor	May 1, 2017	AstraZeneca
Libtayo	cemiplimab-rwlc	PD-1 inhibitor	Sept. 28, 2018	Regeneron / Sanofi
Jemperli	dostarlimab-gxly	PD-1 inhibitor	April 22, 2021	GSK
Yervoy	ipilimumab	CTLA-4 inhibitor	March 25, 2011	Bristol Myers Squibb
Opdualag	nivolumab + relatlimab-rmbw	PD-1 + LAG-3 inhibitor	March 18, 2022	Bristol Myers Squibb
Kymriah	tisagenlecleucel	CD19 CAR-T	Aug. 30, 2017	Novartis
Yescarta	axicabtagene ciloleucel	CD19 CAR-T	October 2017	Kite / Gilead
Tecartus	brexucabtagene autoleucel	CD19 CAR-T	July 24, 2020	Kite / Gilead
Breyanzi	lisocabtagene maraleucel	CD19 CAR-T	February 2021	Bristol Myers Squibb
Abecma	idecabtagene vicleucel	BCMA CAR-T	March 2021	BMS / 2seventy bio
Carvykti	ciltacabtagene autoleucel	BCMA CAR-T	February 2022	Janssen / Legend Biotech
Tecelra	afamitresgene autoleucel	MAGE-A4 TCR-T	Aug. 2, 2024	Adaptimmune / US WorldMeds
Amtagvi	lifileucel	TIL cell therapy	Feb. 16, 2024	Iovance Biotherapeutics
Blincyto	blinatumomab	CD19 x CD3 bispecific	December 2014	Amgen
Kimmtrak	tebentafusp-tebn	gp100 x CD3 bispecific	Jan. 25, 2022	Immunocore
Tecvayli	teclistamab-cqyv	BCMA x CD3 bispecific	Oct. 25, 2022	Janssen
Lunsumio	mosunetuzumab-axgb	CD20 x CD3 bispecific	December 2022	Genentech
Epkinly	epcoritamab-bysp	CD20 x CD3 bispecific	May 2023	Genmab / AbbVie
Columvi	glofitamab-gxbm	CD20 x CD3 bispecific	June 2023	Genentech
Elrexfio	elranatamab-bcmm	BCMA x CD3 bispecific	August 2023	Pfizer
Talvey	talquetamab-tgvs	GPRC5D x CD3 bispecific	Aug. 9, 2023	Janssen
Imdelltra	tarlatamab-dlle	DLL3 x CD3 bispecific	May 16, 2024	Amgen
Thalomid	thalidomide	Immunomodulatory (IMiD)	1998 / myeloma 2006	Celgene / BMS
Revlimid	lenalidomide	Immunomodulatory (IMiD)	Dec. 27, 2005	Celgene / BMS
Pomalyst	pomalidomide	Immunomodulatory (IMiD)	February 2013	Celgene / BMS
TICE BCG	Bacillus Calmette-Guérin	Bacterial immunotherapy	1990	Merck (Organon)
Provenge	sipuleucel-T	Dendritic cell vaccine	April 29, 2010	Dendreon

Revlimid, Pomalyst, and Thalomid are immunomodulatory drugs (IMiDs) rather than classic checkpoint or cellular immunotherapies — they're grouped here because oncology references commonly classify them alongside cancer immunotherapy for their immune-activating mechanism.

PD-1 / PD-L1 Checkpoint Inhibitors

PD-1 (on T cells) and PD-L1 (often on tumor cells) form a "handshake" that tells T cells to stand down. Blocking either side of that handshake with an antibody re-activates the T cell against the tumor.

Keytruda (pembrolizumab)

Target: PD-1  |  Company: Merck  |  First approved: September 4, 2014 (advanced melanoma)

Pembrolizumab is a humanized IgG4 monoclonal antibody that blocks PD-1 from binding PD-L1 and PD-L2. It was the first PD-1 inhibitor ever approved and has since expanded to more than 40 indications spanning lung, head and neck, gastric, cervical, endometrial, hepatocellular, urothelial, renal, and skin cancers, plus tumor-agnostic use in MSI-H/dMMR and high tumor mutational burden cancers. Keytruda is the best-selling drug in the world, and in September 2025 the FDA approved Keytruda Qlex, a subcutaneous formulation that cuts administration time from a 30-minute infusion to roughly 1-2 minutes.

Opdivo (nivolumab)

Target: PD-1  |  Company: Bristol Myers Squibb  |  First approved: December 22, 2014 (advanced melanoma)

Nivolumab, a human IgG4 monoclonal antibody, was the second PD-1 inhibitor approved, arriving less than three months after Keytruda. It's approved across lung, renal, bladder, liver, esophageal, gastric, and colorectal cancers, classical Hodgkin lymphoma, and head and neck squamous cell carcinoma, frequently paired with ipilimumab (Yervoy) as a dual-checkpoint regimen. In March 2026 the FDA approved Opdivo with chemotherapy for previously untreated advanced classical Hodgkin lymphoma in patients 12 and older.

Tecentriq (atezolizumab)

Target: PD-L1  |  Company: Genentech (Roche)  |  First approved: May 18, 2016 (urothelial carcinoma)

Atezolizumab was the first anti-PD-L1 antibody approved for any malignancy. It's a fully humanized IgG1 antibody engineered to avoid depleting PD-L1-expressing T cells. Current approvals span non-small cell and small cell lung cancer, hepatocellular carcinoma, melanoma, alveolar soft part sarcoma, and muscle-invasive bladder cancer, both as monotherapy and combined with chemotherapy or bevacizumab.

Imfinzi (durvalumab)

Target: PD-L1  |  Company: AstraZeneca  |  First approved: May 1, 2017 (bladder cancer)

Durvalumab, a human IgG1 kappa antibody, is best known for the PACIFIC regimen — consolidation therapy after chemoradiation in unresectable stage III non-small cell lung cancer — and has expanded into small cell lung cancer, biliary tract cancer, hepatocellular carcinoma, and endometrial cancer. In 2026, the FDA approved Imfinzi combined with BCG as upfront immunotherapy for high-risk non-muscle-invasive bladder cancer, a setting previously reserved for BCG alone.

Bavencio (avelumab)

Target: PD-L1  |  Company: EMD Serono / Pfizer  |  First approved: March 23, 2017 (metastatic Merkel cell carcinoma)

Avelumab, a human IgG1 lambda antibody, was the first drug ever approved for metastatic Merkel cell carcinoma, an aggressive and rare skin cancer. It's also approved for urothelial carcinoma (as first-line maintenance) and, combined with axitinib, for advanced renal cell carcinoma.

Libtayo (cemiplimab-rwlc)

Target: PD-1  |  Company: Regeneron / Sanofi  |  First approved: September 28, 2018 (advanced cutaneous squamous cell carcinoma)

Libtayo was the first treatment specifically approved for advanced cutaneous squamous cell carcinoma (CSCC). A locally advanced/metastatic basal cell carcinoma indication followed in February 2021, and it's now also approved for first-line non-small cell lung cancer, alone or with chemotherapy.

Jemperli (dostarlimab-gxly)

Target: PD-1  |  Company: GSK  |  First approved: April 22, 2021 (endometrial cancer)

Dostarlimab is a humanized IgG4 anti-PD-1 antibody. Its first approval covered mismatch-repair-deficient (dMMR) endometrial cancer; a broader dMMR/MSI-H solid tumor approval followed in August 2021, and a combination with carboplatin/paclitaxel for primary advanced or recurrent endometrial cancer was added in 2023. Jemperli is central to one of oncology's most closely watched research stories — see the AZUR-1 update below.

CTLA-4 & LAG-3 Checkpoint Inhibitors

Yervoy (ipilimumab)

Target: CTLA-4  |  Company: Bristol Myers Squibb  |  First approved: March 25, 2011 (metastatic melanoma)

Ipilimumab was the first immune checkpoint inhibitor of any kind approved by the FDA, launching the modern checkpoint-inhibitor era three years before the first PD-1 drug. It's a human IgG1 kappa antibody that blocks CTLA-4, a checkpoint expressed on activated T cells that normally dampens immune responses. Today it's most often used alongside a PD-1 inhibitor (nivolumab) for melanoma, renal cell carcinoma, hepatocellular carcinoma, colorectal cancer (MSI-H/dMMR), non-small cell lung cancer, and malignant pleural mesothelioma.

Opdualag (nivolumab + relatlimab-rmbw)

Target: PD-1 + LAG-3  |  Company: Bristol Myers Squibb  |  Approved: March 18, 2022 (unresectable or metastatic melanoma)

Opdualag paired nivolumab with relatlimab, the first LAG-3-blocking antibody ever approved, delivered as a single fixed-dose infusion. In the pivotal RELATIVITY-047 trial, the combination more than doubled median progression-free survival compared with nivolumab alone (10.1 vs. 4.6 months), introducing LAG-3 as cancer immunotherapy's third validated checkpoint target after PD-1/PD-L1 and CTLA-4.

CAR-T Cell Therapies

Chimeric antigen receptor (CAR) T-cell therapy collects a patient's own T cells via apheresis, genetically engineers them in a lab to express a receptor targeting a specific tumor marker, expands them, and reinfuses them as a one-time, personalized treatment.

Kymriah (tisagenlecleucel)

Target: CD19  |  Company: Novartis  |  First approved: August 30, 2017 (pediatric/young adult B-cell ALL)

Kymriah made history as the first CAR-T cell therapy — and the first gene therapy of any kind — approved in the United States. Its approval later expanded to adult diffuse large B-cell lymphoma and follicular lymphoma.

Yescarta (axicabtagene ciloleucel)

Target: CD19  |  Company: Kite / Gilead  |  First approved: October 2017 (large B-cell lymphoma)

Yescarta followed Kymriah by about two months, becoming the second CAR-T therapy approved and the first specifically for large B-cell lymphoma. It later expanded to relapsed/refractory follicular lymphoma.

Tecartus (brexucabtagene autoleucel)

Target: CD19  |  Company: Kite / Gilead  |  First approved: July 24, 2020 (mantle cell lymphoma)

Tecartus uses the same CAR construct as Yescarta but adds a T-cell enrichment manufacturing step that removes circulating tumor cells from the leukapheresis product — important in mantle cell lymphoma, where malignant cells often circulate in the blood. It later expanded to adult B-cell acute lymphoblastic leukemia.

Breyanzi (lisocabtagene maraleucel)

Target: CD19  |  Company: Bristol Myers Squibb  |  First approved: February 2021 (large B-cell lymphoma)

Breyanzi manufactures CD4+ and CD8+ T cells separately before combining them in a defined ratio, a process associated with a somewhat lower rate of severe cytokine release syndrome in practice. Its indications have broadened to chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular lymphoma, and mantle cell lymphoma — the widest CD19 CAR-T label of the group.

Abecma (idecabtagene vicleucel)

Target: BCMA  |  Company: Bristol Myers Squibb / 2seventy bio  |  First approved: March 2021 (relapsed/refractory multiple myeloma)

Abecma was the first CAR-T therapy to target BCMA (B-cell maturation antigen) instead of CD19, opening CAR-T treatment to multiple myeloma. The pivotal KarMMa trial reported a 73% overall response rate in heavily pretreated patients.

Carvykti (ciltacabtagene autoleucel)

Target: BCMA  |  Company: Janssen / Legend Biotech  |  First approved: February 2022 (relapsed/refractory multiple myeloma)

Carvykti is the second BCMA-directed CAR-T approved for multiple myeloma and has since moved into earlier treatment lines based on strong response and progression-free survival data.

Tecelra (afamitresgene autoleucel)

Target: MAGE-A4 (via engineered T-cell receptor)  |  Company: Adaptimmune / US WorldMeds  |  First approved: August 2, 2024 (synovial sarcoma)

Tecelra is a landmark approval: the first engineered cell therapy ever approved for a solid tumor, and the first FDA-approved T-cell receptor (TCR) gene therapy. It's indicated for HLA-A*02:01/02/03/06-positive adults with unresectable or metastatic MAGE-A4-expressing synovial sarcoma who've had prior chemotherapy — the first new treatment option for this rare sarcoma in over a decade. In June 2026 its approval was converted to full approval and extended to pediatric patients 12 and older.

TIL Cell Therapy

Amtagvi (lifileucel)

Type: Tumor-infiltrating lymphocyte (TIL) therapy  |  Company: Iovance Biotherapeutics  |  First approved: February 16, 2024 (advanced melanoma)

Amtagvi is the first FDA-approved treatment built from tumor-infiltrating lymphocytes — T cells harvested directly from a patient's own resected tumor, where they already recognize the cancer's specific markers. After surgical harvest, the TILs are expanded in the lab to the billions and reinfused following lymphodepleting chemotherapy, with several doses of IL-2 given afterward to support their activity. It's a one-time, individualized therapy for adults with unresectable or metastatic melanoma that progressed after a PD-1 blocking antibody and, if BRAF V600-mutant, a BRAF inhibitor with or without a MEK inhibitor. Amtagvi's approval (six months before Tecelra) made it the first cancer cell and gene therapy of any kind approved for a solid tumor.

Bispecific T-Cell Engagers

Bispecific antibodies have two binding arms: one clamps onto CD3 on a T cell, the other onto a marker on the tumor cell, physically bridging the two so the T cell can destroy the cancer cell on contact. Unlike CAR-T and TIL therapy, they're "off-the-shelf" drugs — no individualized cell manufacturing required.

Blincyto (blinatumomab)

Target: CD19 x CD3  |  Company: Amgen  |  First approved: December 2014 (B-cell precursor acute lymphoblastic leukemia)

Blincyto was the original bispecific T-cell engager (BiTE) and remains the template the newer bispecifics below are built on.

Kimmtrak (tebentafusp-tebn)

Target: gp100 x CD3 (ImmTAC bispecific)  |  Company: Immunocore  |  First approved: January 25, 2022 (unresectable/metastatic uveal melanoma)

Kimmtrak is the first therapy of any kind approved for uveal melanoma, a rare eye cancer with historically poor outcomes once metastatic. It's restricted to patients who test positive for the HLA-A*02:01 tissue type, since its T-cell receptor-based design recognizes a gp100 peptide only in that genetic context.

Tecvayli (teclistamab-cqyv)

Target: BCMA x CD3  |  Company: Janssen  |  First approved: October 25, 2022 (relapsed/refractory multiple myeloma)

Tecvayli was the first bispecific antibody approved for multiple myeloma, offering an off-the-shelf alternative to BCMA CAR-T for patients who've exhausted four or more prior lines of therapy.

Lunsumio (mosunetuzumab-axgb)

Target: CD20 x CD3  |  Company: Genentech  |  First approved: December 2022 (relapsed/refractory follicular lymphoma)

Lunsumio is given as a fixed-duration course rather than continuous treatment, allowing eligible patients a treatment-free interval after completing therapy.

Epkinly (epcoritamab-bysp)

Target: CD20 x CD3  |  Company: Genmab / AbbVie  |  First approved: May 2023 (diffuse large B-cell lymphoma)

Epkinly is given subcutaneously rather than by IV infusion, one of the more convenient administration routes among the bispecifics.

Columvi (glofitamab-gxbm)

Target: CD20 x CD3  |  Company: Genentech  |  First approved: June 2023 (diffuse large B-cell lymphoma)

Columvi is engineered with a 2:1 binding format (two CD20 arms to one CD3 arm) intended to strengthen tumor-cell engagement, and is given for a fixed duration.

Elrexfio (elranatamab-bcmm)

Target: BCMA x CD3  |  Company: Pfizer  |  First approved: August 2023 (relapsed/refractory multiple myeloma)

Elrexfio is the second BCMA-directed bispecific approved for myeloma, giving clinicians and patients another off-the-shelf option alongside Tecvayli and the BCMA CAR-T therapies.

Talvey (talquetamab-tgvs)

Target: GPRC5D x CD3  |  Company: Janssen  |  First approved: August 9, 2023 (relapsed/refractory multiple myeloma)

Talvey was the first drug approved against GPRC5D, a novel myeloma target distinct from BCMA, giving patients who've progressed on BCMA-directed therapy another mechanism to try.

Imdelltra (tarlatamab-dlle)

Target: DLL3 x CD3  |  Company: Amgen  |  Accelerated approval: May 16, 2024  |  Full approval: November 19, 2025

Imdelltra was the first bispecific approved for a solid tumor and the first therapy of any kind to target DLL3, a protein expressed on 85-96% of small cell lung cancer cells but minimally on healthy tissue. It's indicated for extensive-stage small cell lung cancer that has progressed on platinum-based chemotherapy. The confirmatory Phase 3 DeLLphi-304 trial — the first global Phase 3 trial in this setting to show a survival benefit over chemotherapy — converted its 2024 accelerated approval to full approval in late 2025.

Immunomodulatory Drugs (IMiDs)

Thalidomide and its two analogues bind cereblon, a component of a cellular protein-degradation complex, triggering a cascade of antiangiogenic, anti-proliferative, and immune-stimulating effects — including activation of T cells and natural killer cells against myeloma cells.

Thalomid (thalidomide)

Company: Celgene / Bristol Myers Squibb  |  Original approval: 1998 (erythema nodosum leprosum)  |  Myeloma indication: 2006

Thalidomide's original 1998 approval covered a complication of leprosy; its multiple myeloma indication (with dexamethasone) followed in 2006, making it the first-in-class IMiD used against cancer and the drug that gave rise to lenalidomide and pomalidomide.

Revlimid (lenalidomide)

Company: Celgene / Bristol Myers Squibb  |  First approved: December 27, 2005 (myelodysplastic syndrome with 5q deletion)  |  Myeloma indication: June 2006

Revlimid is a thalidomide analogue with a substantially different side-effect profile from its parent drug. Its myeloma indication has broadened over time to cover newly diagnosed patients, post-transplant maintenance therapy, mantle cell lymphoma, and follicular lymphoma.

Pomalyst (pomalidomide)

Company: Celgene / Bristol Myers Squibb  |  First approved: February 2013

Pomalyst is the third-generation IMiD, approved for relapsed/refractory multiple myeloma in patients who've already received both lenalidomide and a proteasome inhibitor, including for lenalidomide-resistant disease.

Therapeutic Cancer Vaccines

TICE BCG (Bacillus Calmette-Guérin)

Company: Merck (Organon)  |  Approved: 1990 (non-muscle-invasive bladder cancer)

BCG is a live, attenuated strain of Mycobacterium bovis originally developed as a tuberculosis vaccine. Instilled directly into the bladder, it provokes a local immune response against bladder tumor cells and became the first FDA-approved cancer immunotherapy of any kind — more than two decades before the first checkpoint inhibitor. It remains a standard-of-care treatment for early-stage bladder cancer today, and in 2026 the FDA approved pairing it with durvalumab for upfront use in high-risk disease.

Provenge (sipuleucel-T)

Company: Dendreon  |  Approved: April 29, 2010 (metastatic castration-resistant prostate cancer)

Provenge was the first therapeutic cancer vaccine approved by the FDA. It's manufactured individually for each patient: white blood cells are collected, cultured with a fusion protein linking prostatic acid phosphatase (a prostate cancer antigen) to an immune-stimulating factor, then reinfused. In the pivotal IMPACT trial, it extended median survival by 4.1 months versus placebo in men with asymptomatic or minimally symptomatic disease.

Pipeline to watch: Intismeran autogene (formerly mRNA-4157/V940), a Moderna-Merck personalized mRNA vaccine encoding up to 34 patient-specific tumor neoantigens, is not yet FDA-approved — see the 2025-2026 update section below for its latest trial data.

What's New in 2025-2026

Dostarlimab (Jemperli) and the case for skipping surgery in rectal cancer

The registrational Phase 2 AZUR-1 trial tested dostarlimab alone — no chemotherapy, no radiation, no surgery — in patients with stage II/III mismatch-repair-deficient (dMMR) or MSI-H locally advanced rectal cancer, a subset representing roughly 5-10% of rectal cancers. In July 2026, GSK announced the trial met its primary objective, with a clinically meaningful and sustained complete response rate at 12 months; earlier reporting from the same research group had shown 100% of an initial 12-patient cohort reaching a clinical complete response with no recurrences to date. If confirmed and reviewed by regulators, this data could support dostarlimab as the first immunotherapy able to let some rectal cancer patients avoid the standard triple-modality treatment entirely. This is investigational use built on top of dostarlimab's existing dMMR solid-tumor approval, not yet a separate FDA-labeled indication.

First solid-tumor cell therapies reach the clinic

For seven years after Kymriah's 2017 approval, every CAR-T and cellular immunotherapy was restricted to blood cancers. That changed in 2024: Amtagvi (lifileucel) in February became the first cell therapy approved for a solid tumor (melanoma), and Tecelra (afamitresgene autoleucel) in August became the first engineered TCR-T cell therapy for a solid tumor (synovial sarcoma). Both remain narrowly indicated but are widely viewed as proof-of-concept for extending cellular immunotherapy beyond hematologic malignancies.

A personalized mRNA cancer vaccine posts 5-year data

Intismeran autogene (mRNA-4157/V940), Moderna and Merck's individualized neoantigen mRNA vaccine given alongside Keytruda, isn't FDA-approved yet, but its Phase 2b KEYNOTE-942 trial in resected high-risk melanoma has now reported 5-year follow-up (presented January and June 2026): a sustained 49% reduction in risk of recurrence or death versus Keytruda alone, a 59% reduction in risk of distant metastasis or death, and 68.8% of combination-arm patients cancer-free at five years versus 49.1% on Keytruda alone. Phase 3 trials are enrolling in melanoma, non-small cell lung cancer, renal cell carcinoma, bladder cancer, and cutaneous squamous cell carcinoma; an FDA decision is not expected before 2027 even if those trials confirm the Phase 2 signal.

Bispecific antibodies keep expanding

Since Tecvayli's late-2022 debut, the FDA has approved seven more bispecific T-cell engagers for cancer, most recently converting Imdelltra (tarlatamab) — the first DLL3-targeted bispecific and first bispecific for a solid tumor — from accelerated to full approval in November 2025 based on the confirmatory DeLLphi-304 trial. Bispecifics are increasingly positioned as an off-the-shelf alternative to CAR-T for patients who can't wait through cell-manufacturing timelines or who relapse after CAR-T therapy.

2025 Sales Snapshot: The Big Four Checkpoint Inhibitors

The scale of the checkpoint-inhibitor market illustrates how central these drugs have become to modern oncology:

Drug	Company	2025 Sales	YoY Change
Keytruda	Merck	~$31.7 billion	+7%
Opdivo	Bristol Myers Squibb	$10.05 billion	+8%
Imfinzi	AstraZeneca	$6.06 billion	+28%
Tecentriq	Roche/Genentech	CHF 3.56 billion	+3%

Keytruda alone accounted for roughly 49% of Merck's total 2025 revenue. Its U.S. patent exclusivity is currently expected to run through 2028, and the September 2025 approval of the subcutaneous Keytruda Qlex formulation is widely seen as part of Merck's strategy to extend the franchise's commercial life beyond that date.

Side Effects & Immune-Related Adverse Events

Because these drugs work by ramping up immune activity, their most distinctive risks come from that same immune system attacking healthy tissue rather than only the tumor:

• Checkpoint inhibitors carry a risk of immune-mediated adverse reactions affecting the lungs (pneumonitis), colon (colitis), liver (hepatitis), endocrine glands (thyroid, adrenal, pituitary dysfunction, diabetes), kidneys (nephritis), and skin.
• CAR-T, TIL therapy, and bispecific T-cell engagers carry boxed warnings for cytokine release syndrome (fever, hypotension, hypoxia) and neurologic toxicity/ICANS, which is why administration typically requires an initial inpatient stay or step-up dosing under close monitoring.
• IMiDs (thalidomide, lenalidomide, pomalidomide) carry a boxed warning for embryo-fetal toxicity and are distributed only through a restricted REMS program; blood clot risk is also a key consideration.
• BCG can cause bladder irritation, flu-like symptoms, and rarely a disseminated BCG infection requiring antimycobacterial treatment.

This is a general overview, not a substitute for the full prescribing information or a conversation with the treating oncology team about a specific regimen.

Frequently Asked Questions

What was the first cancer immunotherapy drug ever approved?

BCG (Bacillus Calmette-Guérin), approved in 1990 for bladder cancer, is generally considered the first FDA-approved cancer immunotherapy. Among modern checkpoint inhibitors, ipilimumab (Yervoy) was first, approved in March 2011.

What's the difference between a checkpoint inhibitor and CAR-T therapy?

Checkpoint inhibitors are antibody drugs that release the "brakes" on a patient's existing T cells so they can attack cancer. CAR-T therapy genetically engineers a patient's T cells outside the body to recognize a specific tumor marker before reinfusing them — a one-time, personalized cell product rather than a repeatable drug infusion.

Is immunotherapy the same as chemotherapy?

No. Chemotherapy kills rapidly dividing cells directly. Immunotherapy works by engaging or redirecting the immune system to identify and destroy cancer cells, and it's often combined with chemotherapy rather than used as a straight substitute.

Which is the best-selling immunotherapy drug?

Keytruda (pembrolizumab), with roughly $31.7 billion in 2025 sales, is both the best-selling immunotherapy and the best-selling drug of any kind worldwide.

Can immunotherapy be used for solid tumors, or only blood cancers?

Checkpoint inhibitors have treated solid tumors since 2011. Cellular immunotherapies (CAR-T and TIL therapy) were limited to blood cancers until 2024, when Amtagvi (TIL therapy, melanoma) and Tecelra (TCR-T, synovial sarcoma) became the first cell therapies approved for solid tumors.

What is a bispecific T-cell engager?

It's an antibody engineered with two different binding arms — one that attaches to a T cell (usually via the CD3 receptor) and one that attaches to a marker on the tumor cell — physically bringing the two together so the T cell can kill the cancer cell.

Are Revlimid and Thalomid technically "immunotherapy"?

They're more precisely called immunomodulatory drugs (IMiDs). They don't block a checkpoint or engineer immune cells, but they do activate T cells and natural killer cells against myeloma cells as part of a broader mechanism, which is why oncology references commonly group them with cancer immunotherapy.

Is there an approved cancer vaccine that works like the mRNA COVID-19 vaccines?

Not yet approved. Intismeran autogene (mRNA-4157/V940), an individualized mRNA neoantigen vaccine from Moderna and Merck, is in Phase 3 trials as of 2026, with 5-year data in melanoma showing a sustained reduction in recurrence risk when added to Keytruda. It is not currently FDA-approved.

Asking AI Tools About Immunotherapy Drugs

If you're researching a specific diagnosis with an AI assistant, a little context up front gets you a much more useful answer than a bare drug name.

• Claude / ChatGPT: Name the specific cancer type, stage, and prior treatments (e.g., "PD-L1-positive metastatic NSCLC after first-line chemo") rather than asking generically "what immunotherapy should I take" — these models reason better with a defined clinical scenario and will flag when a question needs a licensed oncologist.
• Gemini: Useful for cross-referencing a specific drug against current NCCN or ASCO guideline language when you ask it to search rather than answer from memory, since checkpoint-inhibitor indications change frequently.
• Perplexity: Well suited to pulling recent trial results (like the AZUR-1 or KEYNOTE-942 updates above) with citations you can then verify against the primary source.

Whichever tool you use, treat the output as a starting point for a conversation with your oncology team, not a substitute for one — dosing, sequencing, and eligibility (like HLA typing for Kimmtrak or biomarker testing for Jemperli) require a clinician with access to your full chart.

Finding a Specialist

Newly diagnosed patients or those exploring a second opinion on immunotherapy eligibility can use our Find a Doctor directory to locate oncology specialists. This is an affiliate link — OneDayMD may earn a commission at no extra cost to you if you use this service.

Medical Disclaimer: This article is for educational purposes only and does not constitute medical advice. Immunotherapy drug eligibility, dosing, and sequencing depend on cancer type, stage, biomarker status, and prior treatment, and must be determined by a qualified oncologist. FDA approval dates, indications, and sales figures reflect publicly reported data as of August 2026 and are subject to change as new approvals, label expansions, and financial reports are issued. Always consult your treating physician before starting or changing any cancer treatment.