Archive | Regulatory

Provectus ocular melanoma treatment gets orphan drug designation

Source: Healio, February 2019 The FDA has granted an orphan drug designation to PV-10, Provectus BioPharmaceuticals’ ocular melanoma treatment candidate, according to a press release. Rose bengal disodium, also called PV-10, is a small molecule oncolytic immunotherapy delivered via intratumoral injection, which can yield immunogenic cell death in solid tumor cancers and stimulate tumor-specific reactivity in […]

Read the full story

Posted in Melanoma News, Regulatory, Publications

Merck’s KEYTRUDA ® (pembrolizumab) Receives Five New Approvals in Japan, Including in Advanced Non-Small Cell Lung Cancer (NSCLC), as Adjuvant Therapy for Melanoma, and in Advanced Microsatellite Instability-High (MSI-H) Tumors

Source: Business Wire, January 2019 KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that KEYTRUDA, Merck’s anti-PD-1 therapy, has simultaneously received five new approvals from the Japan Pharmaceuticals and Medical Devices Agency (PMDA), including three expanded uses in advanced non-small lung cancer (NSCLC), one in melanoma, as […]

Read the full story

Posted in Melanoma News, Regulatory, Publications

FDA approves pembrolizumab for Merkel cell carcinoma

Source: Ecancer News, January 2019 The Food and Drug Administration has granted accelerated approval to pembrolizumab for adult and paediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). Approval was based on Cancer Immunotherapy Trials Network protocol 9 (CITN-09), also known as KEYNOTE-017 (NCT02267603), a multi-centre, non-randomised, open-label trial that enrolled 50 patients […]

Read the full story

Posted in Melanoma News, Regulatory, Publications

NICE green light for Keytruda in melanoma setting

Source: Pharma Times, January 2019 The guidelines apply to adults who have disease that has spread to the lymph nodes and who have already had surgery to remove the tumour and associated lymph glands. Keytruda (pembrolizumab) is a type of immunotherapy that works by boosting the body’s natural defences to fight cancer. In this setting, […]

Read the full story

Posted in Melanoma News, Regulatory, Publications