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PFE's Talzenna sNDA Gets FDA Priority Tag in Wider Prostate Cancer Use
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Key Takeaways
Pfizer's sNDA for Talzenna plus Xtandi received FDA priority review in HRR gene-mutated mCSPC.
The application seeks to expand Talzenna combo use to an earlier stage of metastatic prostate cancer.
Pfizer expects an FDA decision on the Talzenna plus Xtandi sNDA in the last quarter of 2026.
Pfizer (PFE - Free Report) announced that the FDA has accepted the supplemental new drug application (sNDA) for Talzenna (talazoparib), an oral PARP inhibitor, in combination with Xtandi (enzalutamide), an androgen receptor pathway inhibitor (ARPI), for an expanded use in prostate cancer.
The sNDA is seeking approval of Talzenna in combination with Xtandi for treating men with homologous recombination repair (HRR) gene-mutated metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC).
With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected in the last quarter of 2026.
If approved, the sNDA would expand the use of Talzenna plus Xtandi to mCSPC, an earlier stage of the disease. Prostate cancer remains the second most common cancer among men globally.
Talzenna was initially approved in the United States, the EU and several other regions as a monotherapy for adults with deleterious or suspected deleterious gBRCAm HER2-negative locally advanced or metastatic breast cancer. Later, Talzenna, in combination with Xtandi, received FDA approval for treating men with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). The regimen is also approved in the EU for adults with mCRPC in whom chemotherapy is not clinically indicated. The combo is currently authorized in around 60 countries, with indications varying by region.
PFE’s Price Performance
Year to date, shares of Pfizer have gained 3.1% compared with the industry’s rally of 12.2%.
Image Source: Zacks Investment Research
PFE’s sNDA Based on Phase III TALAPRO-3 Study
The sNDA for the Talzenna plus Xtandi combo in mCSPC was based on data from the phase III TALAPRO-3 study.
Data from the same showed that treatment with Talzenna plus Xtandi reduced the risk of radiographic progression or death by 52% versus placebo plus Xtandi, with consistent benefit seen across patients with BRCA and non-BRCA HRR gene alterations.
The safety profile was similar to the known profiles of each agent, while no new safety signals were reported either.
The phase III TALAPRO-3 study enrolled 599 patients with mCSPC, who had received at most three months of androgen deprivation therapy (chemical or surgical), with or without an approved ARP inhibitor in this setting. Eligible patients in the study were randomized to receive Talzenna 0.5 mg/day plus Xtandi 160 mg/day, or placebo plus Xtandi 160 mg/day.
A regulatory filing seeking approval of Talzenna plus Xtandi in HRR gene-mutated mCSPC is also currently under review in the European Union.
Over the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2026 earnings per share have risen from $1.24 to $1.25, while estimates for 2027 have increased from $1.70 to $1.76 during the same time. KNSA shares have soared 51.3% year to date.
Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 1.53%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $4.92 during the same time. LQDA shares have surged 152.4% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.
View the Zacks #1 Rank List
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PFE's Talzenna sNDA Gets FDA Priority Tag in Wider Prostate Cancer Use
Key Takeaways
Pfizer (PFE - Free Report) announced that the FDA has accepted the supplemental new drug application (sNDA) for Talzenna (talazoparib), an oral PARP inhibitor, in combination with Xtandi (enzalutamide), an androgen receptor pathway inhibitor (ARPI), for an expanded use in prostate cancer.
The sNDA is seeking approval of Talzenna in combination with Xtandi for treating men with homologous recombination repair (HRR) gene-mutated metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC).
With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected in the last quarter of 2026.
If approved, the sNDA would expand the use of Talzenna plus Xtandi to mCSPC, an earlier stage of the disease. Prostate cancer remains the second most common cancer among men globally.
Talzenna was initially approved in the United States, the EU and several other regions as a monotherapy for adults with deleterious or suspected deleterious gBRCAm HER2-negative locally advanced or metastatic breast cancer. Later, Talzenna, in combination with Xtandi, received FDA approval for treating men with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). The regimen is also approved in the EU for adults with mCRPC in whom chemotherapy is not clinically indicated. The combo is currently authorized in around 60 countries, with indications varying by region.
PFE’s Price Performance
Year to date, shares of Pfizer have gained 3.1% compared with the industry’s rally of 12.2%.
Image Source: Zacks Investment Research
PFE’s sNDA Based on Phase III TALAPRO-3 Study
The sNDA for the Talzenna plus Xtandi combo in mCSPC was based on data from the phase III TALAPRO-3 study.
Data from the same showed that treatment with Talzenna plus Xtandi reduced the risk of radiographic progression or death by 52% versus placebo plus Xtandi, with consistent benefit seen across patients with BRCA and non-BRCA HRR gene alterations.
The safety profile was similar to the known profiles of each agent, while no new safety signals were reported either.
The phase III TALAPRO-3 study enrolled 599 patients with mCSPC, who had received at most three months of androgen deprivation therapy (chemical or surgical), with or without an approved ARP inhibitor in this setting. Eligible patients in the study were randomized to receive Talzenna 0.5 mg/day plus Xtandi 160 mg/day, or placebo plus Xtandi 160 mg/day.
A regulatory filing seeking approval of Talzenna plus Xtandi in HRR gene-mutated mCSPC is also currently under review in the European Union.
PFE’s Zacks Rank & Stocks to Consider
Pfizer currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Kiniksa Pharmaceuticals (KNSA - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2026 earnings per share have risen from $1.24 to $1.25, while estimates for 2027 have increased from $1.70 to $1.76 during the same time. KNSA shares have soared 51.3% year to date.
Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 1.53%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $4.92 during the same time. LQDA shares have surged 152.4% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.