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FDA Expands AstraZeneca (AZN) Lynparza Label in Prostate Cancer

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AstraZeneca (AZN - Free Report) and Merck (MRK - Free Report) announced that the FDA approved the expansion of their PARP inhibitor Lynparza (olaparib) in prostate cancer indication

The regulatory agency approved the combination of Lynparza with abiraterone and prednisone or prednisolone (“abi/pred”) to treat adult patients with deleterious or suspected deleterious BRCA-mutated (“BRCAm”) metastatic castration-resistant prostate cancer (“mCRPC”).

Following the approval, Lynparza is the first and only PARP inhibitor approved in combination with a new hormonal agent in mCRPC indication.

This is the second indication for Lynparza in mCRPC indication. The AstraZeneca/Merck drug was initially approved in May 2020 as monotherapy for patients with homologous recombination repair (“HRR”) gene-mutated mCRPC, who have progressed following the prior treatment with enzalutamide or abiraterone

Apart from prostate cancer, AstraZeneca/Merck’s Lynparza is approved for certain patients with three other cancer types, namely ovarian, breast and pancreatic.

In the year so far, shares of AstraZeneca have increased 7.4% while Merck has dropped 0.1%. During the same period, the industry has declined 1.0%.

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The latest label-expansion approval is based on the data from the phase III PROpel study, which showed that treatment with Lynparza plus abi/pred demonstrated clinically meaningful improvement in radiographic progression-free survival (“rPFS”) and overall survival (“OS”) endpoints compared with patients who were treated with abi/pred.

In April, the FDA’s Oncologic Drugs Advisory Committee (“ODAC”) voted 11 to 1, with one abstention, in favor of approving Lynparza for the abovementioned expanded use in prostate cancer. The committee voted in favor of the FDA restricting the use of the Lynparza combination to these BRCA-mutated mCRPC patients and not give approval for a broad range of patients with mCRPC. The FDA seems to have followed the advisory committee’s opinion.

Lynparza is already approved in the European Union and several other countries for the treatment of adult patients with mCRPC, based on the PROpel study.

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 includes Koselugo.

As part of the above partnership, AstraZeneca will receive a regulatory milestone payment from Merck which will be recorded by the former as Collaboration Revenue in second-quarter 2023 results.


Zacks Rank & Key Picks

AstraZeneca and Merck carry a Zacks Rank #3 (Hold).Some better-ranked stocks in the overall healthcare sector include Ligand Pharmaceuticals (LGND - Free Report) and Novartis (NVS - Free Report) . While Ligand Pharmaceuticals sports a Zacks Rank #1 (Strong Buy) at present, Novartis carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 30 days, the estimate for Ligand’s 2023 earnings per share has increased from $4.16 to $5.25. During the same period, the earnings estimate per share for 2024 has increased from $4.58 to $4.69. In the year so far, the shares of Ligand have risen 6.6%.

Ligand Pharmaceuticals beat earnings estimates in two of the last four quarters, while missing the mark on the other two occasions. On average, the company’s earnings witnessed an earnings surprise of 21.50%. In the last reported quarter, LGND delivered an earnings surprise of 121.36%.

In the past 30 days, estimates for Novartis’ 2023 earnings per share have increased from $6.60 to $6.67. During the same period, the earnings estimates per share for 2024 have risen from $7.11 to $7.22. Shares of Novartis are up 7.0% in the year-to-date period.

Earnings of Novartis beat estimates in each of the last four quarters, witnessing an average earnings surprise of 5.15%. In the last reported quarter, Novartis’searnings beat estimates by 10.32%.

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