AstraZeneca's Etcamah fails late-stage breast cancer trial
The drug missed its primary endpoint for progression-free survival in combination with palbociclib, despite earlier FDA accelerated approval.
What to know
- Etcamah failed its primary endpoint of improving progression-free survival in combination with palbociclib in a late-stage trial, showing only numerical improvement.
- The drug had received FDA accelerated approval just the week prior for use with CDK4/6 inhibitors, raising questions about the basis for that approval.
- AstraZeneca's stock dropped 3% in aftermarket trading on the announcement.
“AstraZeneca PLC announced Friday that its breast cancer drug Etcamah failed to meet the primary endpoint of improving progression-free survival in a late-stage clinical trial.”
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AstraZeneca Pharmaceutical company developing Etcamah
How it unfolded 2 developments, newest first · click a bar or a number to jump articles
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AstraZeneca shares drop 3% on trial failure announcement
The drugmaker's U.S.-listed shares dropped 3% in aftermarket trading following the announcement of the failed trial endpoint.
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AstraZeneca said that a breast cancer pill failed in a pivotal trial testing it as a first-line therapy in advanced tumors, a result that could limit the use of the medicine. https://www. statnews.com/2026/09/12/astraz eneca-breast-cancer-camizestrant-etcamah-serena-4-trail-failure/
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Etcamah fails primary endpoint in late-stage trial
AstraZeneca announced that Etcamah failed to meet the primary endpoint of improving progression-free survival when tested in combination with palbociclib in previously untreated patients with advanced breast cancer. The combination showed only a numerical improvement in this patient population.
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first by STAT, 10d ago · also Hindustan Times, WSJ
1 more headline
- AstraZeneca Breast-Cancer Drug Misses Goal in Late-Stage Trial Hindustan Times · 9d ago
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2 outlets first by Investing.com News, 12d ago · also Seeking Alpha · read ↗
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background
FDA grants Etcamah accelerated approval for CDK4/6 inhibitor combinations — The U.S. Food and Drug Administration granted accelerated approval for AstraZeneca's Etcamah to be used alongside certain targeted cancer medicines known as CDK4/6 inhibitors.
Also covered reported alongside — the timeline has no entry for these yet
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2 outlets AstraZeneca’s Etcamah flunks first-line breast cancer trial, adding to oral SERDs’ failure record
first by Fierce Pharma, 10d ago · also FirstWord Pharma
1 more headline
- AstraZeneca's oral SERD stumbles in Phase III first-line breast cancer trial FirstWord Pharma · 10d ago
and 2 smaller pieces