FDA Look Into AstraZeneca and Merck’s Ovarian Cancer Drug

The phase 3 PROpel study findings, which demonstrated that Lynparza taken together with Johnson & Johnson’s Zytiga can delay tumor growth and chance of death compared to just taking Zytiga, will be examined by the FDA’s external assessors.

The primary goal will be to determine if Lynparza backs its claim in a large mCRPC demographic, or if the advantages are restricted to a particular subset of patients.

The final patient survival study was given by AstraZeneca and Merck in February. Ultimately, the combination of Lynparza and Zytiga demonstrated a 19% decrease in mortality probability, compared to a previous PROpel trial where almost 50% of the individuals participating did not survive. However, there was little quantifiable difference between them.

Although the BRCA-mutated group had the largest total increase in chance of survival, patterns indicating prolonged survival were seen within patient subsets.

Lynparza received mCRPC approval in the US as a stand-alone treatment if it’s after previous therapy, but only for individuals with HRR mutations.

The FDA convinced pharmaceutical manufacturers to withdraw their PARP inhibitor permits for late-stage ovarian cancer in 2023 after identifying issues.

Use of GSK’s advanced ovarian cancer treatment, Zejula, has been reduced to only include those with BRCA mutations following the FDA’s recommendations.

The company that has potentially been the most negatively impacted by the FDA’s ramped up examination is Clovis Oncology. After removing and restricting Rubraca’s applications for ovarian cancer (their sole commercial product), the business filed for bankruptcy.

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