Pfizer’s TALZENNA® in Combination with XTANDI® Prolongs …
Oct 10, 2024 · XTANDI is currently approved for one or more of these indications in more than 90 countries, including in the U.S., EU, and Japan. Over one million patients have been treated with XTANDI globally. 5. Warnings and Precautions . Seizure occurred in 0.6% of patients receiving XTANDI in eight randomized clinical trials. In a study of patients with ...
Pfizer’s TALZENNA ® in Combination with XTANDI - Business Wire
Oct 10, 2024 · About XTANDI ® (enzalutamide) and Important Safety Information. XTANDI ® (enzalutamide) is an androgen receptor signaling inhibitor. XTANDI is a standard of care and has received regulatory ...
Pfizer’s TALZENNA® in Combination with XTANDI® Prolongs …
6 days ago · The Lancet. NEW YORK, October 10, 2024--Pfizer Inc. (NYSE: PFE) today announced positive topline results from the final prespecified overall survival (OS) analysis of the TALAPRO-2 study of ...
Xtandi Approved for High-Risk Prostate Cancer - NCI
Jan 5, 2024 · With the expanded approval of enzalutamide (Xtandi), oncologists have a new treatment option to offer some patients with prostate cancer who have had a biochemical recurrence.
Phase 3 Study Shows XTANDI® (enzalutamide) plus Leuprolide ... - Pfizer
Mar 16, 2023 · Patients enrolled in the trial were randomized to one of three study arms: XTANDI plus leuprolide, placebo plus leuprolide, or XTANDI monotherapy. The study met its primary endpoint with a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) for patients treated with XTANDI plus leuprolide versus ...
Pfizer and Astellas' XTANDI® Approved by U.S. FDA in Earlier …
Nov 16, 2023 · XTANDI becomes the first and only androgen receptor signaling inhibitor approved for use with or without a GnRH analog therapy* in nonmetastatic castration-sensitive prostate cancer.
Phase 3 Study Shows XTANDI® (enzalutamide) plus Leuprolide ...
Mar 16, 2023 · XTANDI (enzalutamide) is indicated in the U.S. for the treatment of patients with castration-resistant prostate cancer (CRPC) and metastatic castration-sensitive prostate cancer (mCSPC). Warnings...
Pfizer Phase III Prostate Cancer Win Builds Case for Broader
6 days ago · Pfizer on Thursday announced that a combination regimen of its PARP inhibitor Talzenna and ARPI drug Xtandi improved survival in patients with metastatic castration-resistant prostate cancer, according to a topline analysis of the Phase III TALAPRO-2 study.. Specific data in the announcement were sparse, with Pfizer revealing only that Talzenna plus Xtandi led to a “statistically significant ...
Improved Outcomes with Enzalutamide in Biochemically Recurrent …
Oct 18, 2023 · Results. A total of 1068 patients underwent randomization: 355 were assigned to the combination group, 358 to the leuprolide-alone group, and 355 to the monotherapy group. The patients were...
Xtandi cleared by FDA for earlier-stage prostate cancer
Nov 17, 2023 · The FDA has cleared Xtandi (enzalutamide) as a treatment for patients with non-metastatic, castration-sensitive prostate cancer (CSPC) with biochemical recurrence and a high risk of metastasis,...