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llllllllll Gavreto (pralsetinib) / Blueprint Medicines, RocheCStone Pharmaceuticals Announces China’s NMPA has Accepted its New Drug Application with Priority Review Designation for Pralsetinib for the Treatment of Patients with RET Fusion-Positive NSCLC (CStone Pharma Press Release) - Sep 7, 2020 - "CStone Pharmaceuticals...announced that China’s National Medical Products Administration (NMPA) has accepted the company’s New Drug Application (NDA) for pralsetinib for the treatment of RET fusion-positive non-small cell lung cancer (NSCLC) patients previously treated with platinum-based chemotherapy...Pralsetinib showed deep and durable anti-tumor activity with a well-tolerated safety profile in the Chinese cohort of patients with RET fusion-positive NSCLC previously treated with platinum-based chemotherapy. These results were consistent with previously reported data in the global patient population of the ARROW study...Pralsetinib is expected to be China’s first approved RET inhibitor."llllllllll Spravato (esketamine intranasal) / J&JDoctors examine ketamine-like spray as new treatment for depression (Ibtimes) - Sep 7, 2020 - "The National Institute for Health and Care Excellence (Nice) is looking at esketamine...to be applied as nasal spray in order to help treat severe cases of depression. In Nice's second public consultation regarding the draft guidance on the use of esketamine, they are now considering it to treat those who have not responded well to two antidepressants or more....Recent second consultation may reverse the draft guidance that the body has with regards to esketamine and depression....If esketamine would be introduced into the NHS' clinical practice, there would be a need to change the structure and delivery of services."llllllllll Keytruda (pembrolizumab) / Merck (MSD)ICR welcomes approval of immunotherapy for head and neck cancer in Scotland but warns of ‘home nations lottery’ (Institute of Cancer Research) - Sep 7, 2020 - "The Institute of Cancer Research, London, has welcomed the approval by the Scottish Medicines Consortium (SMC) of the immunotherapy, pembrolizumab, as a first-line NHS treatment for some patients with head and neck cancer…But the ICR is concerned that the lack of a similar approval elsewhere in England, Wales or Northern Ireland could herald a ‘home nations lottery’ over cancer treatment….NICE has extended access to pembrolizumab under NHS England guidance during the COVID-19 pandemic until April 2021, but after that access is due to end."llllllllll APG-2575 / Ascentage PharmaAscentage Pharma's Bcl-2 Inhibitor APG-2575 Granted Orphan Drug Designation by the FDA for the Treatment of Chronic Lymphocytic Leukemia (PRNewswire) - Sep 7, 2020 - "Ascentage Pharma....announced that the US Food and Drug Administration (FDA) has granted APG-2575, a novel Bcl-2 inhibitor being developed by the company, an Orphan Drug Designation (ODD) for the treatment of chronic lymphocytic leukemia (CLL)....APG-2575 has received clearances and approvals for multiple Phase Ib/II clinical studies in China, Australia, and the US in a range of hematologic malignancies, including a global Phase Ib/II clinical study of APG-2575 as a single agent or in combination with other therapeutic agents in patients with relapsed/refractory CLL/ SLL (small lymphocytic lymphoma). The study is currently recruiting in US and Australia."llllllllll Imbruvica (ibrutinib) / AbbVie, J&J; Rituxan (rituximab) / Biogen, Zenyaku Kogyo, RocheJanssen Announces European Commission Decision for Expanded Use of IMBRUVICA (ibrutinib) in Combination with Rituximab for Previously Untreated Patients with Chronic Lymphocytic Leukaemia (CLL) (Businesswire) - Sep 7, 2020 - "The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has approved a variation to the marketing authorisation for IMBRUVICA® (ibrutinib), extending the approved indication in chronic lymphocytic leukaemia (CLL) to include combination with rituximab for previously untreated adult patients. The decision is based on data from the Phase 3 E1912 study..."
