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FDA Expands Pfizer's (PFE) Talzenna Label in Prostate Cancer
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Pfizer (PFE - Free Report) announced that the FDA approved the expansion of its PARP inhibitor Talzenna (talazoparib) in prostate cancer indication.
The regulatory agency approved the combination of Talzenna with Xtandi (enzalutamide) to treat adult patients with homologous recombination repair (“HRR”) gene-mutated metastatic castration-resistant prostate cancer (“mCRPC”). Xtandi, also marketed by Pfizer, is a standard of care for prostate cancer patients.
Following the approval, Talzenna is the first and only PARP inhibitor approved in combination with a standard of care in HRR gene-mutated mCRPC. PFE also filed a regulatory filing in the European Union seeking approval for the Talzenna-Xtandi combination in a similar indication, which is currently under review.
This is the second FDA-approved indication for Talzenna. The drug was initially approved in 2018 for treating patients with deleterious or suspected deleterious germline BRCA-mutated (“BRCAm”), HER2-negative locally advanced or metastatic breast cancer.
Shares of Pfizer have lost 23.2% in the year so far against the industry’s 2.0% growth.
Image Source: Zacks Investment Research
The latest label-expansion approval is based on the data from the phase III TALAPRO-2 study, which showed that treatment with Talzenna plus Xtandi demonstrated statistically significant and clinically meaningful in radiographic progression-free survival (“rPFS”) endpoint compared with patients who were treated with Xtandi plus placebo. The Talzenna-Xtandi combo reduced the risk of disease progression or death by 55%.
Now approved in mCRPC indication, Pfizer’s Talzenna will face stiff competition from Lynparza, also a PARP inhibitor, which is jointly marketed by AstraZeneca (AZN - Free Report) and Merck (MRK - Free Report) . AstraZeneca/Merck’s Lynparza is approved for four cancer types, namely ovarian, breast, prostate and pancreatic.
The AstraZeneca/Merck partnered drug is currently approved for treating two indications in prostate cancer.Lynparza was initially approved in May 2020 as monotherapy for patients with HRR gene-mutated mCRPC, who have progressed following the prior treatment with Xtandi or abiraterone. Earlier this month, AstraZeneca/Merck announced that the FDA had granted label expansion to Lynparza to treat adult patients with deleterious or suspected deleterious BRCAm mCRPC.
In the past 60 days, the estimate for Novartis’ 2023 and 2024 EPS have increased from $6.57 to $6.72 and $7.08 to $7.26, respectively. Shares of Novartis are up 11.1% 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%.
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FDA Expands Pfizer's (PFE) Talzenna Label in Prostate Cancer
Pfizer (PFE - Free Report) announced that the FDA approved the expansion of its PARP inhibitor Talzenna (talazoparib) in prostate cancer indication.
The regulatory agency approved the combination of Talzenna with Xtandi (enzalutamide) to treat adult patients with homologous recombination repair (“HRR”) gene-mutated metastatic castration-resistant prostate cancer (“mCRPC”). Xtandi, also marketed by Pfizer, is a standard of care for prostate cancer patients.
Following the approval, Talzenna is the first and only PARP inhibitor approved in combination with a standard of care in HRR gene-mutated mCRPC. PFE also filed a regulatory filing in the European Union seeking approval for the Talzenna-Xtandi combination in a similar indication, which is currently under review.
This is the second FDA-approved indication for Talzenna. The drug was initially approved in 2018 for treating patients with deleterious or suspected deleterious germline BRCA-mutated (“BRCAm”), HER2-negative locally advanced or metastatic breast cancer.
Shares of Pfizer have lost 23.2% in the year so far against the industry’s 2.0% growth.
Image Source: Zacks Investment Research
The latest label-expansion approval is based on the data from the phase III TALAPRO-2 study, which showed that treatment with Talzenna plus Xtandi demonstrated statistically significant and clinically meaningful in radiographic progression-free survival (“rPFS”) endpoint compared with patients who were treated with Xtandi plus placebo. The Talzenna-Xtandi combo reduced the risk of disease progression or death by 55%.
Now approved in mCRPC indication, Pfizer’s Talzenna will face stiff competition from Lynparza, also a PARP inhibitor, which is jointly marketed by AstraZeneca (AZN - Free Report) and Merck (MRK - Free Report) . AstraZeneca/Merck’s Lynparza is approved for four cancer types, namely ovarian, breast, prostate and pancreatic.
The AstraZeneca/Merck partnered drug is currently approved for treating two indications in prostate cancer.Lynparza was initially approved in May 2020 as monotherapy for patients with HRR gene-mutated mCRPC, who have progressed following the prior treatment with Xtandi or abiraterone. Earlier this month, AstraZeneca/Merck announced that the FDA had granted label expansion to Lynparza to treat adult patients with deleterious or suspected deleterious BRCAm mCRPC.
Pfizer Inc. Price
Pfizer Inc. price | Pfizer Inc. Quote
Zacks Rank & Stocks to Consider
Pfizer currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the overall healthcare sector is Novartis (NVS - Free Report) , carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, the estimate for Novartis’ 2023 and 2024 EPS have increased from $6.57 to $6.72 and $7.08 to $7.26, respectively. Shares of Novartis are up 11.1% 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%.