Tag

Nsclc

All articles tagged with #nsclc

health8 days ago•2 min saved

FDA Grants Second National Priority Voucher-Driven Approval for Hernexeos in HER2-Mutant NSCLC

The FDA approved Hernexeos (zongertinib) for adults with unresectable or metastatic non-squamous NSCLC harboring activating HER2 (ERBB2) mutations, extending accelerated approval to first-line patients under the Commissioner's National Priority Voucher (CNPV) pilot program. The decision followed strong data showing 76% of untreated patients had substantial tumor shrinkage, higher than typical 30-45% responses, and came 44 days after filing on Jan 13, 2026. The move underscores fast-tracked review through the CNPV program, which also provides voucher-related benefits; the agency noted Breakthrough Therapy and Priority Review designations and highlighted safety risks such as hepatotoxicity and other common side effects.

via fda.gov|

#health #her2 #hernexeos

business11 days ago•19 min saved

ImmunityBio’s ANKTIVA Delivers 700% Revenue Jump, Expands to 33 Countries and Secures First Lung Cancer Approval

ImmunityBio reports 2025 ANKTIVA net product revenue of about $113 million (up ~700% YoY) with 750% unit growth, expanding approvals to 33 countries across four jurisdictions and securing Saudi Arabia’s first lung-cancer approval, while strengthening European and Middle East partnerships and outlining a 3-year plan to use ANKTIVA as the Cancer BioShield backbone across multiple trials.

via ImmunityBio|

#anktiva #business #immunitybio

health28 days ago•7 min saved

Sunrise advantage: morning immunotherapy linked to longer survival in lung cancer

A randomized study in 210 patients with non-small-cell lung cancer found that receiving the first immunotherapy dose before 3 p.m. significantly improved outcomes compared with later dosing: about 11.3 months progression-free survival versus 5.7 months and roughly 45% alive versus 15% at follow-up, with morning treatment also showing more cancer-killing T cells. Experts caution that replication is needed, though a confirmatory trial is underway; the work was published in Nature Medicine.

via cnn.com|

#cancer #circadian-rhythm #health

healthcare9 months ago•3 min saved

Summit's Lung Cancer Drugs Show Mixed Results in Global Trials

Akeso and Summit Therapeutics' drug ivonescimab showed promising results in delaying progression of certain lung cancers in a global phase 3 trial, with significant improvements in progression-free survival, though overall survival benefits are still being evaluated. The drug demonstrated consistent effects across Asian and Western populations, and the companies plan to seek FDA approval, despite some investor disappointment over the overall survival data.

via Fierce Pharma|

#healthcare #ivonescimab #lung-cancer

healthcare9 months ago•2 min saved

Daiichi and Merck Withdraw Lung Cancer Drug Filing After Survival Data Miss

Merck and Daiichi Sankyo have voluntarily withdrawn their BLA for HER3-DXd, a drug for NSCLC, after phase 3 trial results failed to meet survival endpoints and discussions with the FDA. Despite previous promising data, the drug's development faces setbacks, but the companies remain committed to ongoing research across multiple cancer types.

via Fierce Biotech|

#daiichi-sankyo #fda-withdrawal #healthcare

medical-oncology2 years ago•4 min saved

"ESMO Abstract Leak Unveils Exciting NSCLC Therapies and Neoadjuvant Nivolumab Advancements"

The European Society for Medical Oncology (ESMO) Congress 2023 has experienced an embargo breach, revealing promising therapies for non-small cell lung cancer (NSCLC). Bristol Myers Squibb's Opdivo demonstrated positive results in two Phase III studies, showing a reduction in disease recurrence and improved survival rates. Mirati's adagrasib, when combined with Keytruda, showed strong first-line promise in NSCLC patients. BeiGene's tislelizumab, in combination with chemotherapy, achieved a major pathological response in a Phase III trial. Johnson & Johnson's Rybrevant-lazertinib combination demonstrated potential as a new standard of care for EGFR-mutated NSCLC. These findings will be presented at the ESMO Congress in October.

via BioSpace|

#adagrasib #esmo #medical-oncology