Your search for non small cell lung cancer returned 20 results

The approval was based on data from the KEYNOTE-091 trial.

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.

A PDUFA target date of November 24, 2022 has been set for the application.

To prove clinical benefit, the FDA requires manufacturers to conduct confirmatory trials, also known as a phase 4 studies.

Lorbrena is a third generation ALK tyrosine kinase inhibitor.

Using a blood sample, the test is able to analyze more than 300 cancer-associated genes for alterations.

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.

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.

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.

The approval was based on data from the CASPIAN study, an active-controlled, open-label trial that investigated the combination of durvalumab plus chemotherapy vs chemotherapy alone.