AstraZeneca plc AZN announced that the FDA has granted Breakthrough Therapy designation to its PARP inhibitor, Lynparza (olaparib), for the monotherapy treatment of BRCA1/2 or ATM gene mutated metastatic castration resistant prostate cancer (mCRPC) in patients who have received a prior taxane-based chemotherapy and at least one newer hormonal agent (Zytiga or Xtandi).
We note that Breakthrough Therapy designation requires preliminary clinical evidence demonstrating that a drug may have substantial improvement over available therapy on at least one clinically significant endpoint. The status for Lynparza in this patient population means that the FDA will speed up the review of submission of data within 60 days of receipt.
We are encouraged by the FDA granting Breakthrough Therapy designation to Lynparza for prostate cancer. According to the National Cancer Institute, prostate cancer is the most common cancer among men in the U.S., after skin cancer, resulting in an estimated 27,540 deaths of men in the U.S. in 2015.
Per information provided by AstraZeneca in its press release, there are no approved treatments for third line and above (3L+) mCRPC patients and no targeted therapies are available for mCRPC patients with somatic or germline mutations in BRCA1, BRCA2 or ATM. Upon approval it would provide a new treatment option to patients.
We note that Lynparza was approved in 2014 for the maintenance treatment of women with BRCA-mutated ovarian cancer. The drug has registered sales of $58 million in the first nine months of 2015. Label expansion would boost the drug's sales further.
AstraZeneca is evaluating the potential of Lynparza in other PARP dependent tumors. Currently, phase III studies on Lynparza are ongoing for several indications like gastric cancer and pancreatic cancer among others with additional studies being planned. The company is aiming to bring six new cancer medicines to the market by 2020.
AstraZeneca is a Zacks Rank #2 (Buy) stock. Some favorably ranked stocks in the health care sector include Anika Therapeutics Inc. ANIK, Baxalta Incorporated BXLT and Horizon Pharma plc HZNP. All three carry a Zacks Rank #1 (Strong Buy).
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