AstraZeneca got a split decision from FDA advisors on Thursday, with one cancer drug winning backing and another getting turned away.
The stock was down 1.13% in premarket trading Friday, sitting at $185.25. Over the past month, AZN has dropped roughly 6.9%, while the S&P 500 is up 9.9% over the same period.
The FDA’s Oncologic Drugs Advisory Committee, known as ODAC, reviewed two AstraZeneca cancer treatments on the same day — and came back with very different answers.
On the negative side, the panel voted 6-3 against camizestrant, an oral breast cancer drug being developed as a first-line treatment for HR-positive, HER2-negative advanced breast cancer with ESR1 mutations.
The panel said camizestrant did not show a “meaningful benefit” for patients whose disease had not already progressed on existing therapy.
In clinical trial data from the SERENA-6 study, camizestrant showed a 56% reduction in disease progression or death. Patients on the drug lived a median of 16 months without progression, compared to 9.2 months on the current standard of care.
But the panel raised concerns about the maturity of key secondary data, including overall survival and time to second disease progression, at the time of the interim analysis.
A later pre-planned analysis did show a statistically meaningful PFS2 benefit — 25.7 months versus 19.1 months — and overall survival continued to trend in camizestrant’s favor.
AstraZeneca said it was “disappointed” by the vote but stood behind its data and the drug’s potential for patients.
Morgan Stanley analysts, led by Sarita Kapila, called the result a source of “regulatory overhang and a dent to investor sentiment.”
They noted that approval remains possible, but said the 6-3 vote lowers the likelihood in the SERENA-6 indication. The FDA is not required to follow advisory panel votes, though it typically does. A final agency decision is still expected.
It wasn’t all bad news. On the prostate cancer side, ODAC voted 7-1 in favor of Truqap (capivasertib), used in combination with abiraterone and androgen deprivation therapy for patients with PTEN-deficient metastatic hormone-sensitive prostate cancer.
The recommendation was based on Phase 3 CAPItello-281 trial results, which showed a 19% reduction in the risk of disease progression or death.
Median radiographic progression-free survival reached 33.2 months in the Truqap group, compared to 25.7 months in the control arm.
Secondary endpoints also favored the combination, including delayed progression to castration resistance and improvements in PSA levels.
The safety profile was in line with what’s already known about these therapies, though Grade 3 or higher adverse events were more common in the Truqap group. Overall survival data is still maturing but trends in favor of the combination.
AZN is down roughly flat year-to-date, while the S&P 500 has gained 4.8% over the same period.
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