August 19th 2025
The NCCN has added zongertinib to its guidelines for the care of patients with HER2 (ERBB2)-mutated non–small cell lung cancer.
FDA Approves Bevacizumab Biosimilar for 5 Cancer Types
June 28th 2019The Food and Drug Administration approved bevacizumab-bvzr (Zirabev) – a biosimilar for bevacizumab (Avastin) for the treatment of metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic NSCLC; recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent or metastatic cervical cancer.
New Therapies Are Coming for Lung Cancer With Rare Mutations
May 28th 2019In non–small cell lung cancer (NSCLC), KRAS G12 mutations have been historically difficult to target, and research efforts dedicated to the development of effective targeted therapies for NRG1 fusions have not been successful. However, several biopharmaceutical companies are in the early stages of addressing that challenge, explained Sai-Hong I. Ou, MD, PhD.
FDA Approves New Therapy for Malignant Pleural Mesothelioma
May 24th 2019The FDA has approved the NovoTTF-100L System in combination with pemetrexed and platinum-based chemotherapy for the frontline treatment of patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma (MPM), marking the first treatment for this patient population in more than 15 years.
FDA Expands Pembrolizumab Approval for Lung Cancer
April 12th 2019The FDA has expanded the approval for pembrolizumab (Keytruda) monotherapy for the frontline treatment of patients with stage III non–small cell lung cancer (NSCLC), who are ineligible for surgery or definitive chemoradiation, or metastatic NSCLC, with a PD-L1 expression (tumor proportion score [TPS]) level of ≥1% and do not harbor EGFR or ALK aberrations.
Pemetrexed Approval for Frontline Pembrolizumab/Chemo Combo in NSCLC Gets Expansion
April 10th 2019The FDA expanded the indication for for pemetrexed (Alimta) injection plus pembrolizumab (Keytruda) and platinum-based chemotherapy for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) without EGFR or ALK alterations.
cfDNA Proves Accurate Yet Faster Than Tissue Genotyping in NSCLC Biomarker Identification
March 1st 2019A liquid biopsy test detected all of the guideline-recommended biomarkers in newly diagnosed patients with metastatic non-small cell lung cancer at a similar rate but faster turnaround time to that of tissue genotyping.
FDA Grants Priority Review to Entrectinib for NTRK+ Solid Tumors, ROS1+ NSCLC
February 19th 2019The FDA granted a priority review to entrectinib for the treatment of adult and pediatric patients with NTRK fusion-positive, locally advanced or metastatic solid tumors and for metastatic, ROS1-positive non-small cell lung cancer.
FDA Expands Pemetrexed Approval for Frontline Pembrolizumab/Chemo Combo in NSCLC
January 31st 2019The FDA has expanded the indication for pemetrexed (Alimta) injection in combination with pembrolizumab (Keytruda) and platinum-based chemotherapy for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) without EGFR or ALK alterations.
FDA Accepts sBLA for Frontline Atezolizumab Plus Carboplatin/Nab-Paclitaxel in Nonsquamous NSCLC
January 17th 2019The FDA has accepted a supplemental biologics license application (sBLA) for atezolizumab (Tecentriq), carboplatin, and nab-paclitaxel (Abraxane) as a first-line treatment for patients with metastatic nonsquamous non–small cell lung cancer (NSCLC).
FDA Approves Frontline Atezolizumab Combo for Non-Small Cell Lung Cancer
December 7th 2018The FDA has approved the combination of atezolizumab (Tecentriq), bevacizumab (Avastin), carboplatin, and paclitaxel (ABCP) for the frontline treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC). This indication excludes patients with EGFR/ALK aberrations.
FDA Grants Atezolizumab Combo Priority Review for First-Line Use in SCLC
December 5th 2018The FDA has granted a priority review designation to atezolizumab (Tecentriq) for use in combination with carboplatin and etoposide for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).