non-small cell lung cancer
FDA Approves Hernexeos for Non-Squamous NSCLC with HER2 TKD Activating Mutations
The FDA granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim), for adults with unresectable ...
AUGUST 10, 2025
FDA Grants Accelerated Approval to Zegfrovy for Some Patients With Metastatic NSCLC
The FDA granted accelerated approval to sunvozertinib (Zegfrovy, Dizal [Jiangsu] Pharmaceutical) for adult patients ...
JULY 2, 2025
FDA Grants Accelerated Approval to Datroway for Some Patients With EGFR-Mutated NSCLC
The FDA granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo) for adults with ...
JUNE 24, 2025
FDA Approves Ibtrozi for ROS1-Positive NSCLC
The FDA approved taletrectinib (Ibtrozi, Nuvation Bio), a kinase inhibitor, for adults with locally advanced or ...
JUNE 11, 2025
FDA Grants Accelerated Approval to Emrelis for NSCLC With High C-Met Protein Overexpression
The FDA granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis, AbbVie), a c-Met−directed ...
MAY 20, 2025
FDA Approves Opdivo Qvantig for Subcutaneous Injection
The FDA approved nivolumab plus hyaluronidase-nvhy (Opdivo Qvantig, Bristol Myers Squibb) for subcutaneous ...
DECEMBER 30, 2024
FDA Approves Ensacove for ALK-Positive Locally Advanced or Metastatic NSCLC
The FDA approved ensartinib (Ensacove, Xcovery Holdings) for adult patients with anaplastic lymphoma kinase ...
DECEMBER 19, 2024
FDA Grants Accelerated Approval to Bizengri for NSCLC and Pancreatic Adenocarcinoma
The FDA granted accelerated approval to zenocutuzumab-zbco (Bizengri, Merus N.V.) for adults with the ...
DECEMBER 5, 2024
Breathing New Life Into the NSCLC Pipeline
The next two years may well see an explosion of FDA approvals for non-small cell lung cancer, with some of the ...
NOVEMBER 20, 2024
FDA Approves Neoadjuvant/Adjuvant Opdivo for Resectable NSCLC
The FDA has approved nivolumab (Opdivo, Bristol Myers Squibb) with platinum-doublet chemotherapy as neoadjuvant ...
OCTOBER 4, 2024
Tagrisso Approved for Some With Locally Advanced, Unresectable Stage III NSCLC Following Chemoradiation
The FDA has approved osimertinib (Tagrisso, AstraZeneca) for adult patients with locally advanced, unresectable ...
SEPTEMBER 25, 2024
FDA Approves Rybrevant for NSCLC With EGFR Exon 19 Deletions or L858R Mutations
The FDA has approved amivantamab-vmjw (Rybrevant, Janssen Biotech) with carboplatin and pemetrexed for adult ...
SEPTEMBER 20, 2024