In a pioneering first, AstraZeneca scores FDA OK to use its PARP against breast cancer

AstraZeneca $AZN has picked up another key win for its cancer drug franchise.

The FDA approved its PARP inhibitor Lynparza for BRCA-mutated metastatic breast cancer, offering the pharma giant a path forward to expand its use beyond ovarian cancer. And this is a first in the field.

Pascal Soriot

Their Phase III data made the showcase round at ASCO last summer and is further enhancing the FDA’s focus on drugs that can target cancers triggered by the same genetic causes. The drug was linked with tumor shrinkage in 60% of the patients with germline BRCA1 or BRCA2 mutations taking the drug, compared to 29% in the chemo group. And the OK gives them an edge over their rivals: Clovis’ Rubraca and Tesaro’s Zejula.

Lynparza has been a key part of AstraZeneca CEO Pascal Soriot’s case that oncology represents a big growth opportunity — badly needed after generics chewed up market niches worth billions. Pfizer has a PARP of its own in late-stage development, which will likely further crowd this segment.

The approval is also good news for Merck, which signed a multibillion-dollar development and commercialization deal around Lynparza.

Richard Pazdur

“This class of drugs has been used to treat advanced, BRCA-mutated ovarian cancer and has now shown efficacy in treating certain types of BRCA-mutated breast cancer,” said Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This approval demonstrates the current paradigm of developing drugs that target the underlying genetic causes of a cancer, often across cancer types.”

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VP Oncology Biology
Skyhawk Therapeutics Waltham, MA
Associate Director CMC
Elektroki Boston, MA
Director Process Development
Elektroki Boston, MA
Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT

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