Etcamah (camizestrant) was approved by the FDA on September 4, 2026 to treat hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, the 38th novel drug approval of 2026 on the FDA's Novel Drug Approvals list.
Etcamah (camizestrant), in combination with a CDK4/6 inhibitor, granted accelerated approval for HR-positive, HER2-negative advanced breast cancer with an ESR1 mutation detected in blood during endocrine therapy (Sep 4 2026).
This application had no publicly disclosed goal date at the time of approval. The NDA was accepted in July 2025 on the Phase 3 SERENA-6 trial; the Oncologic Drugs Advisory Committee voted 3-6 against on April 30, 2026; and the FDA extended the PDUFA goal date (announced May 27, 2026) without the new date ever being made public. The FDA granted accelerated approval on September 4, 2026. Per the FDA's announcement, this is the first approval of a cancer therapy guided by detection of a resistance mutation in circulating tumor DNA before imaging shows disease progression; confirmatory studies are required, the Guardant360 CDx assay was authorized as a companion diagnostic, and the label carries a boxed warning for irregular heart rhythm with certain co-administered medications.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: FDA press announcement, September 4, 2026
FDA record of the action: the FDA approved on September 4, 2026, per NDA 220359 ORIG-1 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| OrbiMed Advisors | 915,700 | $171.1 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Yes. The FDA approved the application for Etcamah (camizestrant) on September 4, 2026, per the FDA's own record. The primary source is linked on this page.
Etcamah (camizestrant) is an AstraZeneca PLC (AZN) program. The FDA decision came on September 4, 2026; the FDA's own record of the decision is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), AZN moved -14.2%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.