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Solid Tumors News
FDA Approves Augtyro for NTRK-Positive Advanced Solid Tumors
THURSDAY, June 20, 2024 – The U.S. Food and Drug Administration has approved Augtyro (repotrectinib), a next-generation tyrosine kinase inhibitor (TKI), for the treatment of patients with...
FDA Grants Accelerated Approval to Retevmo (selpercatinib) for Pediatric Patients Two Years and Older with RET-Altered Metastatic Thyroid Cancer or Solid Tumors
On May 29, 2024, the Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for pediatric patients two years of age and older with the following: ...
FDA Approves Augtyro (repotrectinib) for the Treatment of Patients with NTRK-Positive Locally Advanced or Metastatic Solid Tumors
PRINCETON, N.J.--(BUSINESS WIRE) June 13, 2024 – Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Augtyro...
Survival Gains Seen With Assignment to Experimental Group in Cancer Trials
TUESDAY, April 30, 2024 – For patients with solid tumors, assignment to an experimental group in trials of investigational drugs yields significant survival gains, according to a review published...
AACR: Accelerated Aging Linked to Incidence of Early-Onset Cancer
TUESDAY, April 9, 2024 – Accelerated aging (AA) is increasing and is associated with an increased incidence of early-onset solid tumors, according to a study presented at the annual meeting of the...
FDA Expands Pediatric Indication for Rozlytrek (entrectinib) and Approves New Pellet Formulation
On October 20, 2023, the Food and Drug Administration granted accelerated approval to entrectinib (Rozlytrek, Genentech Inc.) for pediatric patients older than 1 month with solid tumors that have a...
Exposure to Low-Dose Ionizing Radiation Linked to Solid Cancer Mortality
MONDAY, Aug. 21, 2023 – Protracted exposure to low-dose ionizing radiation is associated with an increased risk for solid cancer mortality, according to a study published online Aug. 16 in The BMJ....
Jemperli (dostarlimab-gxly) Plus Chemotherapy Approved in the US for dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer
Jemperli is the only immuno-oncology treatment approved in the frontline setting for this patient population in combination with chemotherapy Patients with this type of endometrial cancer face...
FDA Approves Lilly's Retevmo (selpercatinib), the First and Only RET Inhibitor for Adults with Advanced or Metastatic Solid Tumors with a RET Gene Fusion, Regardless of Type
Tumor-agnostic data supporting approval demonstrated an overall response rate (ORR) of 44% across multiple tumor types FDA simultaneously grants traditional approval in adults with locally advanced...
Novartis Tafinlar + Mekinist Receives FDA Approval for First Tumor-Agnostic Indication for BRAF V600E Solid Tumors
Tafinlar + Mekinist, the worldwide targeted therapy leader in BRAF/MEK-inhibition, is the first and only therapy to be approved with a tumor-agnostic indication for adult and pediatric patients with...
GSK Receives FDA Accelerated Approval for Jemperli (dostarlimab-gxly) for Adult Patients with Mismatch Repair-Deficient (dMMR) Recurrent or Advanced Solid Tumors
17 August 2021 Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% across dMMR solid tumors 95% of responders had a duration of response...
FDA Approves Second Biomarker-Based Indication for Merck’s Keytruda (pembrolizumab), Regardless of Tumor Type
KENILWORTH, N.J.--(BUSINESS WIRE) June 17, 2020 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved...
FDA Approves Rozlytrek (entrectinib) for People With ROS1-Positive, Metastatic Non-Small Cell Lung Cancer and NTRK Gene Fusion-Positive Solid Tumors
South San Francisco, CA – August 15, 2019 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved...
FDA Approves Vitrakvi (larotrectinib) for TRK Fusion Cancers
November 26, 2018 – The U.S. Food and Drug Administration today granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific...
FDA Approves Keytruda (pembrolizumab) as First Cancer Treatment for any Solid Tumor with a Specific Genetic Feature
May 23, 2017 – The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time...
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