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Merck announced that the Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) as monotherapy for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

Sun Pharma announced the launch of Infugem (gemcitabine in sodium chloride injection) 10mg/mL for intravenous (IV) use in a ready-to-administer (RTA) bag.

Lorbrena, a third generation ALK tyrosine kinase inhibitor (TKI), has been approved under the accelerated pathway based on tumor response rate and duration of response.

The approval was supported by data from the Phase 3 randomized, double-blind, multicenter, placebo-controlled KEYNOTE-407 trial.

LOXO-292 is being evaluated in the ongoing Phase 1/2 LIBRETTO-001 clinical trial.

Infugem utilizes a novel technology that enables cytotoxic oncology products to be premixed in a sterile setting and to be supplied to prescribers in RTA infusion bags.

Data showed ORR was 14.3% (95% CI, 7.4-24.1) with 2.6% achieving complete response and 11.7% achieving partial response. Of the 11 responders, median DOR was not yet reached at the time of analysis; 91% of patients, however, had a DOR of ≥6 months.

Merck initially gained accelerated approval for Keytruda with Alimta and carboplatin in May 2017.

Study data showed 57% of evaluable patients (N=23) had a partial response and 4% achieved a complete response. Among the 14 responders, 64% did not have significant tumor growths for ≥6 months.

Results showed that progression-free survival (PFS), the primary endpoint, was significantly longer in Tagrisso-treated patients vs EGFR tyrosine kinase inhibitor-treated patients (18.9 months vs 10.2 months; hazard ratio [HR] 0.46, 95% CI: 0.37, 0.57; P <.0001).