The biggest FDA decision drops in 2026 so far: Oncology approvals
Industry Buzz
The FDA approval that had the most direct impact on changing my clinical thinking is full conversion of the tumor mutational burden indication of pembrolizumab... After years of seeing patients come to surgery past the point where anything could be done to help, that fact remains with me.
—Jason Schroder, MD
Recent FDA decisions are also changing the treatment sequence. We're seeing a clear trend toward more frequent use of targeted or combination therapies.
—Simon Khela, MD
The first quarter of 2026 has already reshaped parts of oncology practice. As of March 25, the FDA has issued a cluster of approvals across solid organ and hematological malignancies, all driving toward biomarker-based therapies.
HER2-mutant NSCLC gets a new targeted option
One of the most important solid tumor decisions came on February 26, when the FDA granted accelerated approval to zongertinib for adults with unresectable or metastatic nonsquamous NSCLC with HER2 tyrosine kinase domain activating mutations.[]
In Beamion LUNG-1, the objective response rate was 76%, with 64% of responders maintaining response for at least 6 months and 44% for at least 12 months. For thoracic oncologists, this matters because HER2-mutant lung cancer has had fewer clean frontline options than EGFR- or ALK-driven disease.
Balazs Halmos, MD, MS, put the practice impact plainly on OncLive: “[Zongertinib] really quickly is becoming the first choice because of those favorable characteristics.”[] That comment tracks with the approval package, which highlighted strong response data plus a manageable toxicity profile.
As Simon Khela, MD, medical director of Private Medical Clinic in the UK puts it, “One of the fastest shifts we've witnessed since 2026 was the ongoing growth of biomarker-driven cancer therapies, especially for breast and lung cancer. These approvals are transforming the way that clinicians make the treatment choice earlier toward molecular profiling. In reality, this means that clinicians are increasingly relying on extensive genetic testing prior to diagnosis for guidance on first-line treatment instead of reserving it for later phases.”
BRAF V600E colorectal cancer moves further into frontline care
On February 24, the FDA granted traditional approval to encorafenib in combination with cetuximab and fluorouracil-based chemotherapy for adults with metastatic colorectal cancer with a BRAF V600E mutation.[]
In BREAKWATER, median progression-free survival was 12.8 months vs 7.1 months for control therapy, and median overall survival was 30.3 months vs 15.1 months. In a disease subset long associated with poor prognosis, those numbers stand out.
The agency also flagged this review as an example of Project FrontRunner, which aims to move active drugs into earlier disease settings.
Ovarian cancer treatment gets more biomarker-driven
On February 10, 2026, the FDA approved pembrolizumab, as well as pembrolizumab and berahyaluronidase alfa-pmph, in combination with paclitaxel, with or without bevacizumab, for adults with PD-L1-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma after one or two prior systemic regimens.[]
In KEYNOTE-B96, among patients with PD-L1 CPS, at least one median progression-free survival was 8.3 months vs 7.2 months, and median overall survival was 18.2 months vs 14 months. The FDA also approved PD-L1 IHC 22C3 pharmDx as the companion diagnostic.
Anesthesiologist Jason Schroder, MD, is optimistic: “Right now, the FDA approval that had the most direct impact on changing my clinical thinking is full conversion of the tumor mutational burden indication of pembrolizumab, which the FDA converted from accelerated approval to full approval in early 2025 based on confirmatory data across solid tumor types. After years of seeing patients come to surgery past the point where anything could be done to help, that fact remains with me.”
Emese Zsiros, MD, PhD, FACOG, described the broader shift on OncLive: “[Ovarian cancer] is no longer a homogeneous disease at the time of recurrence, and treatment selection is going to be more biomarker driven.”[] In recurrent ovarian cancer, treatment sequencing now leans harder on PD-L1, folate receptor alpha, and HER2 status than even a few years ago.
Myeloma adds an earlier-line bispecific strategy
Hematologic oncology also moved fast. On March 5, the FDA approved teclistamab plus daratumumab hyaluronidase-fihj for adults with relapsed or refractory multiple myeloma after at least one prior line of therapy that included a proteasome inhibitor and an immunomodulatory agent.[]
The same action converted single-agent teclistamab from accelerated to traditional approval in later-line disease. In MajesTEC-3, median progression-free survival was not reached with the doublet vs 18.1 months with investigator’s choice control, and the overall survival hazard ratio was 0.46.
Surbhi Sidana, MD, called the regimen a “highly effective” option and said the approval would support more patient-centered choices at first relapse.[]
Board-certified oncologist, Sagar Lonial, MD, Professor and Chair of the Department of Hematology and Medical Oncology at the Emory University School of Medicine and member of the International Myeloma Foundation’s Scientific Advisory Board, says, “The approvals of CART and bispecifics in earlier lines of therapy have had a significant impact on changing the way we approach early relapse. Targeting BCMA has become a standard go-to for first or second relapse, given the wealth of data from the CART 4 and MajesTEC-3 trials.”
Board-certified internist Eleonora Fedonenko, MD, adds, “Right now, the FDA's 2026 expansion of bispecific T-cell engager therapies in thoracic oncology is going to change the way physicians initially sequence therapy.”
Hodgkin lymphoma gets a new frontline standard
Dr. Khela adds, “Recent FDA decisions are also changing the treatment sequence. We're seeing a clear trend toward more frequent use of targeted or combination therapies.”
The trend is evident from the March 20, 2026, FDA approval of nivolumab with AVD for adults and adolescents aged 12 and older with previously untreated stage III or IV classical Hodgkin lymphoma.[]
The approval was based on SWOG 1826, in which nivolumab plus AVD improved progression-free survival vs brentuximab vedotin plus AVD, with a hazard ratio of 0.42. The FDA also noted lower peripheral neuropathy rates and fewer treatment discontinuations with the nivolumab regimen.
Alex F. Herrera, MD, said the long-term data support nivolumab plus AVD as “a new standard of care and the first treatment we provide patients who are diagnosed with advanced-stage Hodgkin lymphoma.”[] For clinicians, that line carries weight because the regimen pairs better disease control with a lower toxicity burden than the prior antibody-drug conjugate backbone.
Taken together, the biggest FDA oncology decisions so far this year point in one direction: molecular and biomarker testing, since several 2026 approvals depend on early identification of HER2, BRAF, or PD-L1 status. More molecular selection. The FDA’s docket suggests more label expansions are likely before midyear.