News
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.
News
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.
News
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.
News
The approval was supported by data from the Phase 3 randomized, double-blind, multicenter, placebo-controlled KEYNOTE-407 trial.
Drugs in the Pipeline
LOXO-292 is being evaluated in the ongoing Phase 1/2 LIBRETTO-001 clinical trial.
Uncategorized
The Dako PD-L1 IHC 22C3 PharmDx Assay has been approved as a companion diagnostic to identify patients with with locally advanced or metastatic urothelial carcinoma who are cisplatin-ineligible for treatment with Keytruda.
News
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.
News
Merck initially gained accelerated approval for Keytruda with Alimta and carboplatin in May 2017.
News
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.
News
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).
