News
The approval was based on data from the KEYNOTE-091 trial.
Drugs in the Pipeline
A PDUFA target date of November 24, 2022 has been set for the application.
Drugs in the Pipeline
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
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
In the FLAURA study, the safety and efficacy of osimertinib was compared with standard of care EGFR-tyrosine kinase inhibitors
News
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
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
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.
News
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
The approval was based on data from 83 patients with SCLC who were enrolled in either the KEYNOTE-028 or KEYNOTE-158 trials.