FDA red and green lights: January 2026

January proved to be a quiet month for oncology approvals, delivering just one green light for Darzalex alongside a setback for Atara Biotherapeutics. Johnson & Johnson and Genmab’s anti-CD38 monoclonal antibody secured a front-line multiple myeloma indication, with the FDA approving Darzalex in combination with Velcade, Revlimid and dexamethasone for transplant-ineligible patients, based on the phase 3 Cepheus trial. The decision further strengthens Darzalex’s dominant position in the CD38 space, neutralising the competitive edge previously held by Sanofi’s Sarclisa in this front-line setting. Pierre Fabre and Atara, meanwhile, received a second complete response letter from the FDA for the T-cell therapy Ebvallo, targeting Epstein-Barr virus-positive post-transplant lymphoproliferative disease. According to Atara, the agency concluded that the single-arm Allele study was insufficient to support approval, citing concerns that the trial’s interpretability was confounded by issues related to study design, conduct and analysis. Atara said the manufacturing issues highlighted in the first CRL had since been resolved. If Ebvallo ever gets approved Atara is due a $31m milestone payment from Pierre Fabre, down from the $60m originally specified. Under the amended agreement Atara will be eligible to receive a $15m payment tied to achievement of a future commercial milestone.

Selected January 2026 US regulatory decisions in oncology

Note: VRd= Velcade, Revlimid & dexamethasone. Source: OncologyPipeline.