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AstraZeneca's (AZN) Lynparza sNDA Gets FDA Priority Tag

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AstraZeneca (AZN - Free Report) and partner Merck (MRK - Free Report) announced that the FDA has granted priority review to a supplemental new drug application (sNDA) seeking approval for the expanded use of their PARP inhibitor, Lynparza for patients with metastatic castration-resistant prostate cancer.

The sNDA seeks approval for Lynparza in combination with J&J’s (JNJ - Free Report) prostate cancer drug, Zytiga (abiraterone), and corticosteroid prednisone as a treatment for metastatic castration-resistant prostate cancer (mCRPC). With the FDA granting priority review to the sNDA, a decision is expected in the fourth quarter of 2022. If approved by the FDA, Lynparza with Zytiga will become the first PARP inhibitor to be approved in combination with a new hormonal agent for patients in the mCRPC setting.

The sNDA filing was based on data from the phase III study — PROpel. The study evaluated Lynparza in combination with J&J’s Zytiga (abiraterone) and corticosteroid prednisone in mCRPC patients with or without homologous recombination repair (HRR) gene mutations. These patients also had not received any prior therapy in the mCRPC setting., including new hormonal agents (NHAs) or chemotherapy.

Data from the study showed that treatment with Lynparza in combination with J&J’s Zytiga reduced the risk of disease progression or death by 34% versus Zytiga alone in the above patient population.

In prostate cancer, Lynparza is presently approved for treating HRR gene-mutated mCRPC (BRCA-mutated and other HRR gene mutations) in the United States based on data from the PROfound phase III study.

This year so far, AstraZeneca’s shares have risen 14.7% compared with an increase of 0.4% for the industry in the said time frame.

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At present, Lynparza, is approved for four cancer types, ovarian, breast, prostate and pancreatic for various patient populations. It has been used to treat over 40,000 patients worldwide. Lynparza is also being evaluated in an earlier-line setting for the approved cancer indications as well as some other cancer types. Lynparza is being jointly developed and commercialized by AstraZeneca and Merck.

In a separate press release, AstraZeneca announced that a phase III study, DESTINY-Breast02, evaluating it and partner Daiichi Sankyo’s drug Enhertu in previously treated HER2-positive metastatic breast cancer met the primary endpoint. In the study, Enhertu demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to physician’s choice of treatment in the above-mentioned patient population. The study also met the key secondary endpoint of improved overall survival.

DESTINY-Breast02 is the confirmatory study for Enhertu’s current breast cancer indication in Europe and several other countries. As such, AstraZeneca/Daiichi Sankyo will submit these data to regulatory authorities

Zacks Rank & Stocks to Consider

AstraZeneca has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

A better-ranked stock in the biotech sector is Alkermes (ALKS - Free Report) , which has a Zacks Rank #2 (Buy).

Alkermes’ estimates for 2022 have improved from a loss of 16 cents to earnings of 20 cents over the past 30 days. Earnings estimates for 2023 have gone up from 32 cents to 50 cents over the same time frame. Shares of Alkermes have risen 14.4% this year so far.

Earnings of Alkermes beat estimates in all the last four quarters, delivering a surprise of 325.48%, on average.


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