Allergan, Amgen, Gilead, Lilly, Merck & Co, and Pfizer Lead Pipeline NewsBy
A roundup of the latest pipeline news, including from the pharmaceutical majors, featuring news from Amgen, Allergan, Eli Lilly, Gilead Sciences, and Merck & Co. Inc.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday June 7, 2017 to Tuesday June 13, 2017.
Amgen, Allergan Move Biosimilar to Roche’s Avastin Forward
Amgen and Allergan report that the Oncologic Drugs Advisory Committee of the US Food and Drug Administration (FDA) will review data supporting the biologics license application for ABP 215, a biosimilar candidate to Roche’s Avastin (bevacizumab), an anticancer drug.
The Committee will review analytical, pharmacokinetic, and clinical data from studies involving ABP 215, including results from a Phase III study in patients with non-squamous non-small cell lung cancer (NSCLC). The Phase III study met its primary endpoint showing clinical equivalence to bevacizumab. Safety and immunogenicity of ABP 215 were also comparable to bevacizumab.
ABP 215 is a biosimilar candidate to bevacizumab, a recombinant immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that binds to vascular endothelial growth factor (VEGF) and inhibits the interaction of VEGF with its receptors, VEGF receptor-1 and VEGF receptor-2, thus inhibiting establishment of new blood vessels necessary for the maintenance and growth of solid tumors.
The FDA has set a Biosimilar User Fee Act target action date of September 14, 2017, for ABP 215.
Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of 10 biosimilars in its portfolio, one which has been approved by the FDA.
Merck & Co. Pauses Clinical Trial on Immuno-Oncology Drug Keytruda
Merck & Co. Inc. has provided an update on two combination studies of Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, in the blood cancer, multiple myeloma. Merck has accepted the external Data Monitoring Committee recommendation to pause new enrollment on KEYNOTE-183 and KEYNOTE-185, two studies exploring Keytruda treatment in combination with other therapies in multiple myeloma. The pause is to allow for additional information to be collected to better understand more reports of death in the Keytruda groups. Patients currently enrolled in these two studies will continue to receive treatment. Other studies of Keytruda continue unchanged.
KEYNOTE-183 is a Phase III study comparing pomalidomide and low-dose dexamethasone with Keytruda to pomalidomide and low-dose dexamethasone alone in patients with refractory or relapsed and refractory multiple myeloma who have undergone at least 2 lines of prior treatment. KEYNOTE-185 is a Phase III study comparing lenalidomide and low-dose dexamethasone with Keytruda to lenalidomide and low-dose dexamethasone alone in patients with newly diagnosed and treatment-naïve multiple myeloma who are ineligible for autologous stem cell transplant.
Source: Merck & Co. Inc.
Pfizer and Lilly Receive Fast-Track Status for Osteoarthritis Drug
Pfizer and Eli Lilly and Company report that the US Food and Drug Administration (FDA) has granted fast-track designation for tanezumab for the treatment of chronic pain in patients with osteoarthritis) and chronic low back pain.
Tanezumab is an investigational humanized monoclonal antibody that selectively targets, binds to and inhibits nerve growth factor (NGF). NGF levels increase in the body as a result of injury, inflammation or in chronic pain states. By inhibiting NGF, tanezumab may help to keep pain signals produced by muscles, skin, and organs from reaching the spinal cord and brain. Tanezumab has a mechanism that acts in a different manner than opioids and other analgesics, including nonsteroidal anti-inflammatory drugs.
In 2013, Pfizer and Lilly entered into a worldwide co-development and co-commercialization agreement for the advancement of tanezumab.
Gilead Sciences Submits NDA to FDA for HIV Drug
Gilead Sciences has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen containing bictegravir (50 mg) (BIC), a an investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) for the treatment of HIV-1 infection in adults.
Gilead plans to submit a marketing authorization application for BIC/FTC/TAF in the European Union in the third quarter of 2017.
Source: Gilead Sciences