AstraZeneca Disappointed With US FDA Committee's Lynparza Vote Outcome
02 Mai 2023 - 8:58AM
Dow Jones News
By Anthony O. Goriainoff
AstraZeneca PLC said Tuesday it was disappointed with the
outcome of the U.S. Food and Drug Administration's Oncologic Drugs
Advisory Committee vote on its Lynparza cancer treatment in
conjunction with abiraterone and prednisone.
The Anglo-Swedish pharmaceutical company said the committee, or
ODAC, recognized the treatment's favorable risk profile but voted
11 to one, with one abstaining, that the indication should be
limited to patients whose tumors have a breast cancer gene, or
BRCA, mutation.
In August the FDA granted Lynparza in combination with
abiraterone a priority review for the treatment of adult patients
with metastatic castration-resistant prostate cancer.
The company said then that Lynparza, when combined with
abiraterone, reduced the risk of disease progression or death by
34% versus abiraterone alone.
"While we are pleased with the recognition of the benefit of
Lynparza plus abiraterone for patients with BRCA-mutated metastatic
castration-resistant prostate cancer, we are disappointed with the
outcome of today's ODAC meeting. We strongly believe in the results
of the PROpel trial, which demonstrated the clinically meaningful
benefit for this combination in a broad population of patients
regardless of biomarker status," the company said.
Write to Anthony O. Goriainoff at
anthony.orunagoriainoff@dowjones.com
(END) Dow Jones Newswires
May 02, 2023 02:43 ET (06:43 GMT)
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