FDA Oncology Chief Sets Out His Agenda — and Narrows the Etcamah Precedent

The FDA’s new oncology chief used his first interview to warn that last week’s Etcamah clearance sets no precedent for ctDNA-triggered accelerated approvals; meanwhile, Lilly closed its $3.8 billion acquisition of AtaiBeckley and moved a psychedelic-derived compound into Phase 3 for treatment-resistant depression.

Today’s top developments:

• In his first interview as director of the FDA’s Oncology Center of Excellence, Angelo de Claro cautioned that AstraZeneca’s Etcamah (camizestrant) accelerated approval does not establish molecular progression as a validated regulatory endpoint, checking sponsors that had read the clearance as opening the door to ctDNA-triggered accelerated approvals (Fierce Pharma)
• Eli Lilly completed its acquisition of AtaiBeckley — $6.75 per share up front plus up to $2.50 in contingent value rights, roughly $3.8 billion — taking the psychedelic-derived compound mebufotenin (BPL-003) into Phase 3 for treatment-resistant depression alongside MDMA- and DMT-based programs (Eli Lilly)
• Novartis fell 13% on the week after a third program setback in eight days — pelacarsen, del-desiran and rapcabtagene autoleucel — and dragged Amgen and Eli Lilly down with it despite neither reporting data of its own, a sign the market is repricing whole categories rather than one company’s execution (BioSpace)
• NICE issued draft guidance against NHS funding of Gilead’s Yeytuo (lenacapavir) as twice-yearly HIV pre-exposure prophylaxis, concluding the injectable is not value for money, with a second evaluation committee meeting set for November 3, 2026 (Pharmaceutical Technology)
• Takeda R&D president Andy Plump will retire in June 2027 with no successor named, opening a nine-month search whose outcome will signal whether the company runs out the pipeline he rebuilt or fills its post-2027 gap by acquisition (Pharmaphorum)