Updated: FDA punts PDUFA date for another indication for AstraZeneca, Merck’s cancer drug Lynparza

The FDA says not yet to two Big Pharmas on their collaborative PARP inhibitor’s newest indication — it needs three more months to review.

AstraZeneca and Merck said Thursday that the delay for the supplemental NDA is to “provide further time for the full review of the submission.” The companies said in a statement that they will continue to work with FDA to facilitate the agency’s review.

The pharmas’ application seeks approval from the federal regulator for Lynparza, combined with either abiraterone and prednisone or prednisolone, for patients with metastatic castration-resistant prostate cancer. According to previous guidance from AstraZeneca, the original PDUFA date would’ve been before the end of 2022, pushing the new date into early next year.

This is the most recent update for a drug that had an indication voluntarily pulled earlier this year. The companies decided to withdraw the drug for patients with deleterious or suspected deleterious gBRCAm advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

Cristian Massacesi

Per a letter sent out in late August, AstraZeneca CMO Cristian Massacesi said that a subgroup analysis indicated a potential negative effect on overall survival (OS) for Lynparza compared to the chemotherapy control arm in a subgroup of patients in a randomized Phase III study.

Lynparza, or olaparib, is a PARP inhibitor that targets DNA damage repair machinery in cancer cells, causing them to die. First approved in 2014, it’s been approved as a maintenance agent in multiple lines of therapy for ovarian cancer, as well as metastatic breast cancer.

The sNDA for Lynparza was filed after data emerged from the Phase III PROpel trial, results that were published in NEJM earlier this year. Data showed at the time that the combo treatment reduced the risk of disease progression or death by 34% compared to placebo, which contained abiraterone and prednisone or prednisolone. Median progression-free survival was 24.8 months for the Lynparza plus abiraterone arm, compared to 16.6 months for the placebo plus abiraterone arm.

Analysts with SVB Securities noted after the announcement that “given some of the emerging concerns for the PARP inhibitor class, we think it is possible the FDA asked AZN for more information on OS data/trends, including for the HRD- subgroup, where the asset may be less efficacious.” The analysts further added that it is possible that FDA is concerned about the risk/benefit profile for the PARP class in certain subgroups of patients.

Editor’s note: This story has been updated to include an analyst note from SVB Securities.

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