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FDA expands Pfizer’s Talzenna-Xtandi label to hormone-sensitive prostate cancer

The FDA expanded Pfizer's Talzenna-Xtandi label into hormone-sensitive prostate cancer, Bayer won first approval for asundexian in China, and AstraZeneca's claudin ADC cut the risk of death 53% in CLDN18.2-positive GI cancers.
pharminent October 27, 2026

Pharminent · Daily Brief
October 27, 2026

Regulatory & Approvals

FDA expands Pfizer’s Talzenna-Xtandi label to hormone-sensitive prostate cancer
The FDA expanded the label for Pfizer’s Talzenna in combination with Xtandi to hormone-sensitive prostate cancer, moving the combination to an earlier line of therapy.
PharmExec →$PFE

Bayer’s asundexian approved in China for secondary stroke prevention
Bayer’s oral Factor XIa inhibitor asundexian has been cleared in China for secondary stroke prevention, its first market approval.
Pharmaphorum →$BAYRY

Clinical Data

AstraZeneca’s claudin ADC cuts risk of death 53% in GI cancers
AstraZeneca’s CLARITY-Gastric01 trial of sone-ve in CLDN18.2-positive gastrointestinal cancers showed a 53% reduction in the risk of death, doubling survival.
Pharmaphorum →$AZN

Roche reports positive lung cancer data for KRAS drug divarasib
Roche presented data at ESMO from a study of its KRAS inhibitor divarasib in lung cancer, described as one of the meeting’s more impressive data sets.
STAT →$RHHBY

Bristol Myers Squibb discloses patient death in CAR-T multiple sclerosis trial
Bristol Myers Squibb disclosed a patient death in a clinical trial of its CAR-T cell therapy in multiple sclerosis.
PharmExec →$BMY

BioNTech and DualityBio report modest ADC benefit in HER2-low breast cancer
BioNTech and DualityBio said their antibody-drug conjugate produced a “modest” benefit in a breast cancer study, with the companies describing the treatment’s impact in HER2-low breast cancer as “limited.”
BioPharma Dive →$BNTX

Orpathys Phase III SANOVO data support first-line use in NSCLC subgroup
Positive Phase III results from the SANOVO and SAFFRON studies backed first-line use of Orpathys in a non-small cell lung cancer subgroup, though adverse events tempered the reaction.
Pharmaceutical Technology →

GSK’s ris-rez shows benefit in osteosarcoma study at ESMO
A new study presented at ESMO suggests GSK’s ris-rez could improve treatment of osteosarcoma, a cancer with few treatment improvements in decades.
Pharmaphorum →$GSK

Deals & Partnerships

Pathos AI enters collaboration with Bristol Myers Squibb
Pathos AI has entered into a collaboration with Bristol Myers Squibb.
PharmExec →$BMY

Business & Finance

Corxel to go public via SPAC merger with $300M financing
Obesity drugmaker Corxel Pharmaceuticals will go public through a SPAC merger backed by a $300 million financing, with two GLP-1 and amylin-targeting medicines in hand; the merger is expected to close in the first half of 2027, when Corxel plans to begin a Phase 3 trial of its oral GLP-1.
BioPharma Dive →

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