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Industry News

  • FDA Approves Levnatinib + Pembrolizumab for Advanced RCC

    On August 10, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of lenvatinib plus pembrolizumab for first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

    Read the FDA announcement.

    Read the Eisai announcement.

    Posted 8/16/2021



  • FDA Approves Pembrolizumab for High-Risk, Early-Stage TNBC

    On July 27, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab for the treatment of patients with high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery.

    Read Merck's announcement.

    Posted 7/27/2021



  • FDA Approves Pembrolizumab + Lenvatinib for Advanced Endometrial Cancer

    On July 22, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of pembrolizumab plus lenvatinib for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation. 

    Read the FDA announcement.

    Read the Merck announcement.

    Read the Eisai Inc. announcement

    Posted 7/22/2021



  • FDA Grants Regular Approval + New Indication to Enfortumab Vedotin-ejfv

    On July 9, 2021, Astellas Pharma Inc. and Seagen Inc. announced that the U.S. Food and Drug Administration (FDA) has granted regular approval to enfortumab vedotin-ejfv. The FDA also approved a new indication for enfortumab vedotin-ejfv for adult patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and who have previously received one or more prior lines of therapy.

    Read the FDA announcement.

    Read the SeaGen announcement.

    Posted 7/9/2021


  • FDA Approves Expanded Indication for Pembrolizumab for cSCC

    On July 6, 2021, the U.S. Food and Drug Administration (FDA) approved an expanded label for pembrolizumab as a monotherapy treatment for patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

    Read Merck's announcement.

    Posted 7/6/2021


  • Updated Data for Durvalumab

    Durvalumab (Imfinzi®, AstraZeneca) offers the best chance for long-term survival in a curative intent setting. This update comes after the post-hoc analysis of 5-year overall and progression-free survival data had been released for the PACIFIC trial, a large, Phase III, randomized, double-blind, placebo-controlled, multicenter study of 713 patients with unresectable Stage III NSCLC. The primary overall survival analysis was reported at 2 years (25.2 months median follow-up). For more information, click here

    Posted 6/10/2021



  • FDA Approves Sotorasib for KRAS G12C-Mutated NSCLC

    The U.S. Food and Drug Administration (FDA) has approved sotorasib (LUMAKRASTM, Amgen) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. Sotorasib has received accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    Read press release.

    Posted on 6/1/2021



  • ZYNLONTA Added to NCCN Guidelines

    I am pleased to inform you that the NCCN Guidelines® have been updated to include loncastuximab tesirine-lpyl (ZYNLONTA™, ADC Therapeutics) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma.

    NCCN Guidelines recommend loncastuximab tesirine-lpyl (ZYNLONTA™) as a third-line and subsequent therapy option for patients with relapsed or refractory DLBCL who have received ≥2 systemic therapies.

    For more information, visit adctherapeutics.com

    INDICATION AND USAGE

    ZYNLONTA is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma.

    This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    See full prescribing information.


    Posted 5/27/2021


  • ADC Therapeutics Announces Data from LOTIS-2 Study

    Data from the LOTIS-2 trial of loncastuximab tesirine-lpyl ( ZYNLONTA™, ADC Therapeutics), including efficacy and safety results, have been published in Lancet Oncology.

    Read the full LOTIS-2 study publication here.

    INDICATION AND USAGE

    ZYNLONTA is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma.

    This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    See full prescribing information.


    Posted 5/27/2021


  • FDA Approves Nivolumab for Completely Resected Esophageal or GEJ Cancer

    On May 20, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy.

    Read the FDA announcement.

    Read the Bristol Myers Squibb announcement.

    Posted 5/21/2021




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