FDA Delays Decision on AstraZeneca (AZN), Merck's Lynparza sNDA
AstraZeneca AZN and partner Merck MRK announced that the FDA extended the review period for their supplemental new drug application (“sNDA”) seeking approval for expanded use their blockbuster PARP inhibitor Lynparza in metastatic castration-resistant prostate cancer (mCRPC) indication
The FDA extended the review period by another three months to further review this sNDA submission despite the filing being accepted for priority review. Prior to the extension, a decision from the regulatory authority was expected by this year’s end. The FDA decision should now come sometime in March 2023.
The sNDA seeks label expansion for Lynparza in combination with J&J’s JNJ prostate cancer drug, Zytiga (abiraterone), and corticosteroid prednisone or prednisolone for mCRPC in patients for whom chemotherapy is not clinically indicated.
The sNDA is supported by data from the phase III study — PROpel. In the study, Lynparza plus J&J’s Zytiga and prednisone or prednisolone reduced the risk of disease progression or death by 34% versus Zytiga alone. Median radiographic progression-free survival (rPFS) was 24.8 months in the Lynparza plus Zytiga arm versus 16.6 months for Zytiga alone.
Lynparza is already approved in the U.S. as monotherapy for patients with HRR gene-mutated mCRPC who have been previously treated with J&J’s Zytiga or Pfizer’s Xtandi (enzalutamide) based on the PROfound phase III study.
This year, AstraZeneca’s shares have risen 19.7% compared with the industry’s 13.9% rise.
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AstraZeneca/Merck also submitted a regulatory filing seeking a similar label expansion for Lynparza in Europe. Last month, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the approval of Lynparza for the expanded use in prostate cancer. Similar regulatory filings are also being reviewed in other countries.
AstraZeneca markets Lynparza in partnership with Merck. The profit-sharing deal between AstraZeneca and Merck was inked in 2017. In addition to Lynparza, the deal included Koselugo.
Lynparza is approved for four cancer types, namely ovarian, breast, prostate and pancreatic. The PARP inhibitor is also being evaluated in an earlier-line setting for the approved cancer indications and some other cancer types.
In the first nine months of 2022, Lynparza generated product sales of $1.95 billion for AstraZeneca and alliance revenues of $825 million for Merck.
AstraZeneca PLC Price
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Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold).A better-ranked stock in the overall healthcare sector is BioNTech BNTX which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, estimates for BioNTech’s 2022 earnings per share have risen from $34.47 to $35.38. During the same period, the loss estimates per share for 2023 have narrowed from $16.97 to $17.53. Shares of BioNTech have lost 29.4% in the year-to-date period.
Earnings of BioNTech beat estimates in three of the last four quarters and missed the mark once, witnessing a surprise of 58.99% on average. In the last reported quarter, BNTX delivered an earnings surprise of 92.35%.
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