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Pfizer seeks approval from US FDA for Covid-19 treatment

Pharmaceutical Technology

The latest filing is based on non-clinical and clinical data for Paxlovid and also comprised data from the Phase II/III EPIC-HR clinical trial. The safety data currently available for the therapy is in line with over 3,500 Paxlovid-treated subjects across the EPIC clinical development programme.

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Enhertu significantly improved both progression-free and overall survival in DESTINY-Breast04 trial in patients with HER2-low metastatic breast cancer

The Pharma Data

Enhertu is a HER2-directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo. 1,2 HER2-low expression occurs in both HR-positive and HR-negative disease.3. All patients in the trial received a HER2 test, and the results were centrally confirmed.

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The latest advances in breast cancer therapy

Drug Discovery World

Antibody drug conjugate MBRC-101 MBrace Therapeutics presented preclinical data demonstrating the potential of its novel antibody drug conjugate MBRC-101 for the treatment of solid tumours including hormone receptor-positive (HR+) and triple negative breast cancers. months of additional follow-up and 78.3% The results show a 25.1%

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Update on FDA Advisory Committee vote on Lynparza plus abiraterone for metastatic castration-resistant prostate cancer

The Pharma Data

We strongly believe in the results of the PROpel trial, which demonstrated the clinically meaningful benefit for this combination in a broad population of patients regardless of biomarker status.” maturity, HR of 0.81, 95% CI 0.67-1.00; 0.43) and OS (HR of 0.29, 95% CI, 0.14-0.56). 0.81; p<0.001). months and 16.6

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FDA Approves

The Pharma Data

This approval was based on an exploratory subgroup analysis of the Phase 3 PROpel trial which showed that LYNPARZAplus abi/pred demonstrated clinically meaningful improvements in both radiographic progression-free survival (rPFS) (HR=0.24 [95% CI, 0.12-0.45]) 0.45]) and overall survival (OS) (HR=0.30 [95% CI, 0.15-0.59])

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Gilead and Kite Oncology Demonstrate Growing Hematology Pipeline and Strength of Leading Cell Therapy Portfolio at EHA

The Pharma Data

“The presentation of longer-term follow-up data from our pivotal studies and real-world evidence reinforce the potential of cell therapy across different blood cancers, lines of treatment and settings,” said Frank Neumann, MD, PhD, Senior Vice President, Global Head of Clinical Development, Kite. “We

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Update on FDA Advisory Committee Vote on LYNPARZA® (olaparib) Plus Abiraterone and Prednisone or Prednisolone in First-Line Metastatic Castration-Resistant Prostate Cancer

The Pharma Data

We strongly believe in the results of the PROpel trial, which demonstrated a clinically meaningful benefit for this combination in a broad population of patients regardless of biomarker status.” In exploratory analyses of the BRCA m subgroup, patients in the LYNPARZA plus abi/pred arm had fewer rPFS (HR=0.23 [95% CI, 0.12-0.43])

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