Amgen Logo

Amgen Submits Applications in the US and Europe for Expanding Current Indication For XGEVA (denosumab) to Include Patients with Multiple Myeloma

April 4, 2017 Amgen has announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and an application for a variation to the marketing authorization to the European Medicines Agency (EMA) for XGEVA® (denosumab). These submissions to regulatory authorities seek to expand the currently approved XGEVA indication for the prevention of skeletal-related events … Continue reading Amgen Submits Applications in the US and Europe for Expanding Current Indication For XGEVA (denosumab) to Include Patients with Multiple Myeloma

Novartis logo - luca dezzani

EU approves Novartis drug combination Tafinlar + Mekinist for BRAF V600-positive advanced non-small cell lung cancer (NSCLC)

APR 03, 2017 Novartis has announced the European Commission has approved Tafinlar®(dabrafenib) in combination with Mekinist® (trametinib) for treating patients with BRAF V600-positive advanced or metastatic non-small cell lung cancer (NSCLC). This approval marks the first targeted treatment approved for the patient population, who previously had few treatment options, in all 28 member states of the … Continue reading EU approves Novartis drug combination Tafinlar + Mekinist for BRAF V600-positive advanced non-small cell lung cancer (NSCLC)

FDA Approves Tesaro’s niraparib for ovarian cancer

March 27, 2017 The FDA has given approval to Tesaro for the use of its PARP drug niraparib, which will now be marketed as Zejula as a maintenance therapy for the treatment of recurrent ovarian cancer. Tesaro had argued that the efficacy data for niraparib qualified for an approval for use in patients who are either … Continue reading FDA Approves Tesaro’s niraparib for ovarian cancer

FDA lifts its hold on vadastuximab talirine after Seattle Genetics adds new safeguards

March 6, 2017 The FDA has given Seattle Genetics the green light to continue the trials for its armed antibody dubbed SGN-CD33A (vadastuximab talirine) used for the treatment of acute myeloid leukemia. The biotech says it is implementing additional risk mitigation measures in all vadastuximab talirine studies, including “revised eligibility criteria and stopping rules for veno-occlusive disease.” … Continue reading FDA lifts its hold on vadastuximab talirine after Seattle Genetics adds new safeguards

Novartis logo - luca dezzani

Novartis gets FDA Approval for LEE011 for frontline use against breast cancer

March 13, 2017 Novartis has gained the FDA approval for LEE011, its CDK 4/6 drug now approved as a frontline therapy for postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer in combination with any aromatase inhibitor. Also known as ribociclib, the drug hits the market as Kisqali with … Continue reading Novartis gets FDA Approval for LEE011 for frontline use against breast cancer

U.S. FDA and EMA Accepts Three Marketing Applications for Ertugliflozin-Containing Medicines for Adults with Type 2 Diabetes, Announced by Merck and Pfizer

March 6, 2017 Merck and Pfizer Inc. have announced that the U.S. Food and Drug Administration (FDA) has accepted for review three New Drug Applications (NDAs) for medicines containing ertugliflozin, an investigational SGLT2 inhibitor in development for helping to improve glycemic control in adults with type 2 diabetes: one for monotherapy, one for the fixed-dose … Continue reading U.S. FDA and EMA Accepts Three Marketing Applications for Ertugliflozin-Containing Medicines for Adults with Type 2 Diabetes, Announced by Merck and Pfizer

FDA Accepts the Biologics License Application for Avelumab for the Treatment of Metastatic Urothelial Carcinoma

February 28, 2017 EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, and Pfizer Inc. have announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for avelumab for Priority Review as a treatment for patients with locally advanced or metastatic urothelial carcinoma (mUC) with disease progression on … Continue reading FDA Accepts the Biologics License Application for Avelumab for the Treatment of Metastatic Urothelial Carcinoma

Celgene Logo

REVLIMID (Lenalidomide) Approved by the European Commission as Monotherapy for the Maintenance Treatment of Patients with Newly Diagnosed Multiple Myeloma

Feb 24, 2017 Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, has announced that the European Commission (EC) has approved REVLIMID® (lenalidomide) as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation (ASCT). REVLIMID® is the first and only licensed maintenance treatment available to these patients. Multiple myeloma is … Continue reading REVLIMID (Lenalidomide) Approved by the European Commission as Monotherapy for the Maintenance Treatment of Patients with Newly Diagnosed Multiple Myeloma

Novartis logo - luca dezzani

Novartis drug Zykadia receives FDA Priority Review for first-line use in patients with ALK+ metastatic NSCLC

February 23, 2017 Novartis has announced that the US Food and Drug Administration (FDA) accepted the supplemental New Drug Application (sNDA) of the company for filing, and granted Priority Review for the expanded use of Zykadia® (ceritinib) as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase … Continue reading Novartis drug Zykadia receives FDA Priority Review for first-line use in patients with ALK+ metastatic NSCLC

Roche logo

Roche receives EU approval of Alecensa (alectinib) for people with previously treated ALK-positive non-small cell lung cancer

21 February 2017 Roche has announced that the European Commission has granted a conditional marketing authorisation for Alecensa® (alectinib) as monotherapy for treating adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. Within one year of treatment, most people with ALK-positive NSCLC develop resistance to the current … Continue reading Roche receives EU approval of Alecensa (alectinib) for people with previously treated ALK-positive non-small cell lung cancer