Updated weekly · 3 upcoming meetings
Upcoming FDA Advisory Committee meetings (ODAC, CRDAC, PCAC, PSPAC, and others) — the reviews that move biotech stocks. Sponsor, ticker, indication, and briefing-doc link for each. Refreshed from FDA and Federal Register weekly.
Indication: HR+/HER2- locally advanced or metastatic breast cancer with emergent ESR1 mutation during first-line endocrine-based therapy
NDA 220359 — camizestrant (oral SERD) in combination with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) for HR+/HER2- breast cancer upon ESR1 mutation emergence. SERENA-6 data. Morning session.
Indication: Metastatic hormone-sensitive prostate cancer (mHSPC), PTEN-deficient, in combination with abiraterone
sNDA 218197/S-004 — Truqap (capivasertib) tablets in combination with abiraterone for PTEN-deficient mHSPC. CAPItello-281 trial. Afternoon session.
Indication: N/A (compounding)
Two-day meeting (July 23-24) to discuss bulk drug substances nominated for inclusion on the Section 503A Bulk Drug Substances List (drugs compounding pharmacies may use).
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