Relatlimab/Nivolumab Application for Frontline Advanced Melanoma Validated by EMA

Breaking News Melanoma Research

October 1, 2021 Kristi Rosa REPOST from OncLive The European Medicines Agency has validated its marketing authorization application for the fixed-dose combination of relatlimab and nivolumab in the frontline treatment of adult and pediatric patients with advanced melanoma. Jonathan Cheng The European Medicines Agency has validated its marketing authorization application for the fixed-dose combination of relatlimab and nivolumab (Opdivo) in … Read More

FDA Takes Steps Aimed at Improving Quality, Safety and Efficacy of Sunscreens

For Immediate Release: September 24, 2021 (repost from FDA) The U.S. Food and Drug Administration today took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter (OTC) drugs. In the short term, these new authorities essentially preserve status quo marketing conditions for these sunscreens. However, the agency … Read More

Immunotherapy treatment may be appropriate for patients with earlier stages of melanoma

Breaking News Melanoma Research

Source: University of Pittsburgh (September 20, 2021) An immunotherapy called pembrolizumab reduced cancer recurrence after surgery in patients with stage IIb and IIc melanoma, according to the results of an international, randomized phase III clinical trial led by UPMC Hillman Cancer Center. These results indicate that this immunotherapy treatment-; which currently is approved only for stage III and IV melanomas-; … Read More

USDA Accepts for Priority Review Bristol Myers Squibb’s Application for LAG-3-Blocking Antibody Relatlimab and Nivolumab Fixed-Dose Combination as Treatment for Patients with Unresectable or Metastatic Melanoma

Breaking News Melanoma Research

09/20/2021 The application is based on Phase 2/3 RELATIVITY-047 trial, in which the relatlimab and nivolumab fixed-dose combination demonstrated a statistically significant and clinically meaningful progression-free survival benefit over Opdivo monotherapy U.S. Food and Drug Administration assigns a target action date of March 19, 2022 PRINCETON, N.J.–(BUSINESS WIRE)– Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) … Read More

Adjuvant Immunotherapy Prolongs Recurrence-Free Survival in Resected Stage II B/C Melanoma

Breaking News Melanoma Research

LUGANO, Switzerland – The first randomised phase III clinical trial in stage II melanoma has shown a 35% reduction in the risk of recurrence with adjuvant pembrolizumab compared with placebo. The late breaking results of the KEYNOTE-716 trial are presented at the ESMO Congress 2021. (1) Patients with stage IIB and IIC melanoma have a deep or ulcerated primary tumour. These patients … Read More

Nouscom Begins Phase Ib Trial of Personalized Vaccine, Keytruda Combo in Melanoma, Lung Cancer

Breaking News Melanoma Research

August 24, 2021  Expands DecisionDx®-Melanoma Coverage to Veterans Health Administration and Military Health System Medical Centers NEW YORK – Nouscom said on Tuesday it has dosed the first patient in a Phase Ib trial of its neoantigen cancer vaccine, NOUS-PEV, plus pembrolizumab (Merck’s Keytruda) in patients with advanced melanoma and non-small cell lung cancer. The trial is evaluating the combination as a … Read More

Castle Biosciences Awarded U.S. Federal Supply Schedule Contract for DecisionDx-Melanoma

Breaking News Melanoma Research

August 24, 2021 07:00 AM Eastern Daylight Time Expands DecisionDx®-Melanoma Coverage to Veterans Health Administration and Military Health System Medical Centers FRIENDSWOOD, Texas–(BUSINESS WIRE)–Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to inform treatment decisions, today announced that it has been awarded a five-year U.S. Federal Supply Schedule (FSS) contract from the Veterans Health Administration … Read More

FDA Orphan Drug Designation Granted to Melanoma Drug Alrizomadlin

Breaking News Melanoma Research

July 21, 2021 (repost) Sara Karlovitch The FDA has granted an orphan drug designation to alrizomadlin, an MDM2-p53 inhibitor, for the treatment of stage 2b to 4 melanoma. The FDA has granted an orphan drug designation (ODD) to alrizomadlin (APG-115), an MDM2-p53 inhibitor, for the treatment of stage 2b to 4 melanoma, according to a press release by Ascentage Pharma.1 … Read More

Gut Microbes Signal Response to Immune Therapy in Melanoma

(re-post from original article in GEN News) Programmed cell death protein 1 (PD-1) and CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) are proteins found on the surface of immune cells that downregulate immune response. The inhibition of these proteins—dual immune checkpoint therapy–constitutes the most effective approach for activation of anti-tumor immune responses in the treatment of many types of cancers. Although combined … Read More

EORTC and Pierre Fabre Partner to Address Treatment Gap for Stage II Melanoma Patients

Partnership builds on complementary strengths to advance research in melanoma with a focus on Stage II melanoma patients EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER Brussels, Belgium; Castres, France (29 June 2021) – European Organisation for Research and Treatment of Cancer (EORTC) and Pierre Fabre today announced a strategic partnership in support of patients with resected Stage 2 BRAF-mutant … Read More