FDA red and green lights: February 2026

February may be the shortest month of the year, but it delivered a decent amount of oncology approvals.

Among the most notable, Boehringer secured the only accelerated approval of the month, with the second indication for its HER2 inhibitor Hernexeos, in first-line HER2-mutant lung cancer. The clearance marks a first for an oncology drug, given that it was granted under the new US commissioner’s national priority voucher (CNPV) programme.

A combination of Braftovi and Erbitux secured full approval, formalising an accelerated green light granted in 2024. The decision was based on progression-free survival and overall survival data from the Breakwater trial, the same study that had backed the earlier accelerated nod.

Pancreatic cancer also showed momentum, with Novocure securing approval for its Optune Pax tumour-treating fields device. Phase 3 Panova-3 data showed that the addition of the device to gemcitabine and Abraxane extended median overall survival to 16.2 months, compared with 14.2 months for chemotherapy alone. 

Checkpoint inhibition continued to expand, as Merck & Co won approval for both intravenous and subcutaneous formulations of Keytruda in second and third-line PD-L1-positive platinum-resistant ovarian cancer, based on data from the Keynote-B96 study.

Haematological cancers

In haematological cancers Gilead strengthened the label of its Car-T therapy Yescarta, removing primary central nervous system from the limitations of use section. The change was supported by data from an investigator-initiated study. 

Meanwhile, AstraZeneca and AbbVie secured the first approval for a fixed-duration combination regimen of Calquence and Venclexta in front-line chronic lymphocytic leukaemia. 

The Amplify trial showed the chemo-free combination reducing risk of progression or death by 35%, with median PFS not yet reached versus 47.6 months for chemoimmunotherapy.

As for the Hernexeos approval, that took longer than expected after the agency pushed back a decision from December to February. Despite the delay, this allowed Boehringer to outpace its rival HER2 inhibitor Hyrnuo, from Bayer. The decision relied on Beamion-Lung1 data showing a 76% response rate, including complete responses in 8% of 72 previously untreated patients. 

Selected February 2026 US regulatory decisions in oncology

Note: AA=accelerated approval. Source: OncologyPipeline.