Archive | Regulatory

FDA Approval Sought for Extended Pembrolizumab Dosing Schedule for Select Indications

Source: OncLive, July 2019 The FDA has accepted 6 supplemental biologics license applications (sBLAs) for review to update the dosing schedule for pembrolizumab (Keytruda) to include an every-6-weeks option at 400 mg over 30-minute infusions.1 The new dosage would be applicable for the PD-1 inhibitor’s following indications: melanoma, Merkel cell carcinoma, gastric cancer, hepatocellular carcinoma, classical […]

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Posted in Melanoma News, Regulatory, Publications

Immunocore’s Lead Asset Tebentafusp Gains Fast Track Designation for Metastatic Uveal Melanoma

Source: Business Wire, May 2019 OXFORD, England & CONSHOHOCKEN, Pa.–(BUSINESS WIRE)–Immunocore Limited, a leading T Cell Receptor (TCR) biotechnology company, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its development program, the investigation of tebentafusp (IMCgp100) for the treatment of patients who are HLA-A*0201-positive with previously untreated, metastatic uveal […]

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Posted in Melanoma News, Regulatory, Publications

Is your melanoma hot enough for immunotherapy?

Source: Science Daily, May 2019 Melanomas tend to be “hot” or “cold” — if they’re hot, immunotherapy lights melanoma tumors like beacons for elimination by the immune system; but 40-50 percent of melanomas are cold, making them invisible to the immune system, and patients with cold tumors tend to show little benefit from immunotherapies. The […]

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Posted in Melanoma News, Regulatory, Publications

Novel Immunotherapy Tebentafusp Granted Fast Track Designation for Metastatic Uveal Melanoma

Source: Targeted Oncology, May 2019 The FDA has granted tebentafusp (IMCgp100) a fast track designation for the treatment of patients with HLA-A*0201-positive previously untreated metastatic uveal melanoma, according to Immunocore Limited, the company developing the novel immunotherapy agent. In findings from a phase I study, tebentafusp demonstrated an overall survival (OS) rate of 74% at […]

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Posted in Melanoma News, Regulatory, Publications

2019 Events

Calculate your risk of getting melanoma Sunscreen calculator
Map of body for recording areas of skin causing you concern on your body Target Therapy Finder