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FDA grants breakthrough therapy designation to Lynparza for certain types of prostate cancer
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The FDA granted breakthrough therapy designation to olaparib for monotherapy treatment of BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer, according to a press release from the drug’s manufacturer.
The designation specifically relates to use of olaparib (Lynparza, AstraZeneca) in patients who received a prior taxane-based chemotherapy and at least one newer hormonal agent, such as abiraterone acetate (Zytiga, Janssen) or enzalutamide (Xtandi; Astellas, Medivation).
Olaparib, an oral PARP inhibitor, is designed to exploit tumor DNA repair pathway deficiencies to preferentially kill cancer cells, according to the press release.
The FDA based its decision on results of the phase 2 TOPARP-A trial, which showed olaparib induced response in men with prostate cancer with defective DNA damage repair mechanisms.
“The breakthrough therapy designation for Lynparza is encouraging news for patients, and their families, as there are currently very limited treatment options for metastatic castration-resistant prostate cancer,” Antoine Yver, head of oncology, global medicines development, for AstraZeneca, said in a press release. “We will work closely with the FDA to introduce Lynparza as a new treatment option as soon as possible.”
Olaparib already is approved for use in women with pretreated BRCA-mutated ovarian cancer. Phase 3 studies are evaluating the agent in patients with gastric cancer, pancreatic cancer and BRCA-mutated breast cancer.