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.
Your search for non small cell lung cancer returned 17 results
Features
Indications Withdrawn as FDA Evaluates Several Accelerated Approvals
To prove clinical benefit, the FDA requires manufacturers to conduct confirmatory trials, also known as a phase 4 studies.
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Lorbrena Approved for First-Line Treatment of ALK-Positive Metastatic NSCLC
Lorbrena is a third generation ALK tyrosine kinase inhibitor.
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FDA Approves Blood-Based Test as Companion Diagnostic for Multiple Cancer Drugs
Using a blood sample, the test is able to analyze more than 300 cancer-associated genes for alterations.
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.
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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.
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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.
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FDA Approves Imfinzi for Extensive-Stage Small Cell Lung Cancer
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.
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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…
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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.
