AstraZeneca said the FDA committee voted 11 to one, with one abstaining, to limit its Lynparza treatment to patients whose tumors have a breast cancer gene, or BRCA, mutation. Read More...
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 AZN UK:AZN 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.
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