The FDA approved subcutaneous versions of Johnson & Johnson’s Rybrevant and Roche’s Lunsumio in December, part of seven oncology approvals that month as the agency resumed a faster review pace following a government shutdown.
J&J’s subcutaneous Rybrevant, marketed as Rybrevant Faspro, was cleared for the same indications as the intravenous formulation. The anti‑EGFR x cMet bispecific can be used in combination with Lazcluze in first‑line EGFR‑mutated non‑small cell lung cancer. J&J says the SC formulation can be administered in five minutes versus several hours for the IV version. The Paloma‑3 trial also showed a trend toward improved survival compared with the IV formulation. Rybrevant Faspro’s approval follows a complete response letter issued about a year earlier that J&J attributed to manufacturing issues.
Roche received accelerated approval for Lunsumio Velo, the subcutaneous version of its anti‑CD20 T‑cell engager, limited to third‑line follicular lymphoma in line with the current status of the IV product. The decision had been delayed from September so the FDA could review additional data. The IV confirmatory trial, Celestimo, has been pushed into this year after an earlier timetable that targeted 2025. Roche is also advancing Lunsumio into diffuse large B‑cell lymphoma, where the Sunmo study showed positive results for Lunsumio plus Polivy in the second line.
AstraZeneca and Daiichi Sankyo won approval for Enhertu in first‑line HER2‑positive breast cancer, expanding the drug’s largest approved use and supporting the companies’ projections for multimillion‑dollar peak sales. AstraZeneca estimates about 135,000 patients are addressable in the frontline setting and is pursuing additional perioperative indications. Roche also secured approval for Perjeta in first‑line breast cancer.
Eli Lilly’s Jaypirca received full approval for use in patients with chronic lymphocytic leukemia after a prior accelerated approval. The decision covers post‑BTK inhibitor patients and follows the BRUIN CLL‑321 confirmatory trial, which demonstrated a progression‑free survival benefit but not an overall survival benefit. Lilly is also advancing earlier‑line studies, with positive front‑line data presented at ASH.
Boehringer Ingelheim’s Hernexeos for first‑line HER2‑mutated NSCLC is widely expected to receive a decision imminently. The submission benefits from a commissioner’s national priority voucher; the company has said it has no formal PDUFA date but stands ready to respond to FDA inquiries within 24 hours under the program.
Bristol Myers Squibb expanded its CD19‑targeting CAR‑T Breyanzi into relapsed or refractory marginal zone lymphoma, ahead of competitors including Gilead’s Yescarta and Novartis’s Kymriah. The approval highlights practical challenges with CAR‑T: of 77 leukapheresed patients, 67 received Breyanzi. The intent‑to‑treat overall response rate was 84% and rose to 96% among those who received the therapy. Marginal zone lymphoma is a relatively rare, indolent subtype.
December’s approvals reflect renewed regulatory momentum and a continued push by companies to move oncology therapies earlier in the treatment continuum.
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