News
Keytruda Approved as Adjuvant Treatment for Stage IB, II, or IIIA NSCLC
The approval was based on data from the KEYNOTE-091 trial.
Your search for non small cell lung cancer returned 22 results
Drugs in the Pipeline
Poziotinib Under Review for Previously Treated HER2 Exon 20 Insertion Mutation Positive NSCLC
A PDUFA target date of November 24, 2022 has been set for the application.
Drugs in the Pipeline
FDA Passes on Poziotinib for HER2 Exon 20 Insertion Mutation Positive NSCLC
According to the CRL, the application could not be approved in its present form as additional data, including a randomized controlled trial, would be required.
News
Cyramza Plus Erlotinib Approved for First-Line Metastatic NSCLC With EGFR Mutations
The FDA has approved Cyramza (ramucirumab; Lilly) in combination with erlotinib, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
News
Significant Improvement in Overall Survival With Osimertinib in EGFR-Mutated NSCLC
In the FLAURA study, the safety and efficacy of osimertinib was compared with standard of care EGFR-tyrosine kinase inhibitors
News
FDA Panel Votes on Ramucirumab for First-Line Treatment of Metastatic EGFR-Positive NSCLC
The Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee voted 6 to 5 that ramucirumab (Cyramza; Lilly) plus erlotinib demonstrated a favorable benefit/risk profile for patients with untreated metastatic epidermal growth factor receptor (EGFR)-positive non-small cell lung cancer (NSCLC). The vote was based on data from the phase 3 RELAY study (N=449), which evaluated…
News
Opdivo Plus Yervoy Approved for First-Line Treatment of Metastatic NSCLC
The FDA has approved the combination of Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
News
Keytruda Approved for BCG-Unresponsive, High-Risk Non-Muscle Invasive Bladder Cancer
The Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab; Merck) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
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Opdivo Plus Yervoy With Limited Chemotherapy Approved for First-Line Metastatic or Recurrent NSCLC
The Food and Drug Administration (FDA) has approved the combination of Opdivo (nivolumab; Bristol Myers Squibb) plus Yervoy (ipilimumab; Bristol Myers Squibb) and 2 cycles of platinum-doublet chemotherapy, for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
News
Keytruda Approved to Treat Metastatic Small Cell Lung Cancer
The approval was based on data from 83 patients with SCLC who were enrolled in either the KEYNOTE-028 or KEYNOTE-158 trials.
