AstraZeneca (AZN - Free Report) announced two positive regulatory updates from the FDA for its cancer drugs namely Lynparza and Imfinzi
The FDA granted priority review for the supplemental new drug application (sNDA) seeking label expansion for its PARP inhibitor, Lynparza, in patients with HRR-mutated metastatic castration-resistant prostate cancer (mCRPC). A decision is expected in the second quarter of 2020.
The sNDA was filed based on positive data from the phase III PROfound study evaluating Lynparza in patients with mCRPC whose disease has progressed on prior treatment with new hormonal anticancer treatments. The patient population evaluated in the study has a qualifying tumor mutation in one of 15 genes involved in the HRR pathway, including among them BRCA1/2, ATM and CDK12. Data from the study showed that treatment with the drug led to a 51% reduction in the risk of disease progression or death compared to hormone therapies — J&J’s (JNJ - Free Report) Zytiga (abiraterone) or Pfizer’s (PFE - Free Report) Xtandi (enzalutamide).
Earlier this month, another sNDA for Lynparza seeking its approval for the drug in combination with Roche’s (RHHBY - Free Report) chemotherapy, Avastin (bevacizumab), as first-line maintenance treatment for advanced ovarian cancer patients was also granted priority review by the FDA. A decision is expected in the second quarter of 2020.
Shares of AstraZeneca have rallied 40.4% in the past year compared with the industry’s growth of 14.4%.
In a separate press release, AstraZeneca announced that the FDA granted Orphan Drug designation to Imfinzi (durvalumab) and pipeline candidate, tremelimumab — as a potential treatment for hepatocellular carcinoma (“HCC”), the most common type of liver cancer.
Imfinzi is already approved as a treatment for previously treated metastatic urothelial carcinoma (bladder cancer) and non-small cell lung cancer. The company is developing the drug as monotherapy or in combination regimens in several clinical studies to expand its label in several cancer indications. It is also developing tremelimumab in combination with Imfinzi targeting multiple cancer indications including HCC.
Imfinzi achieved blockbuster status in 2019. Sales of the drug increased more than 180% year over year in the first nine months of 2019 to $1.05 billion. It is also the second highest revenue generator in AstraZeneca’s oncology portfolio. Successful completion of ongoing clinical studies will likely continue the rapid growth in sales of the drug going forward.
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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