The European Commission (EC) has approved Merck and Pfizer’s Bavencio (avelumab), in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). Both companies say that the approval made as a result of positive interim results from the Phase III JAVELIN Renal 101 study, which found that the combination
Pfizer’s lorlatinib has been assigned a “Promising Innovative Medicine” award for the treatment of some patients with ALK-positive advanced non-small cell lung cancer. The drug is currently under review by the European Medicines Agency for patients with the condition who have previously been treated with a second generation ALK tyrosine kinase inhibitor. The PIM award
European Commission has approved Pfizer’s Xeljanz (tofacitinib citrate) for ulcerative colitis (UC), meaning it is the first oral therapy and Janus kinase inhibitor to be approved for this patient population. The drug is now approved for three indications in the EU, which also includes rheumatoid arthritis and psoriatic arthritis. “Until now, people living with moderately
The FDA have issued a complete response letter concerning Pfizer’s filing for a biosimilar version of Roche’s blockbuster cancer drug Herceptin. The FDA asked for more technical information, but Pfizer emphasised that it does not relate to safety or clinical data contained in the application. Although more information was not released, Pfizer said it is
Regulators in the EU and US are reviewing three new submissions for medicines containing ertugliflozin, an investigational SGLT2 inhibitor being developed by Merck and Pfizer to aid improvement of glycaemic control in adults with type II diabetes.
Merck and Pfizer’s bid to bring PD-1/PD-L1 inhibitor to market is now proceeding, after the EU regulator kicked off a review of avelumab for Merkel cell carcinoma. The drug’s marketing application is based on the results from the JAVELIN Merkel 200 study which were presented at this year’s ADCO meeting, from patients with the rare
NICE Issue Draft Guidance for Pfizer’s Lung Cancer Drug but Removes Janssen and Novartis Drugs from Funding.
NICE have issued new draft guidance in the UK meaning some patients with lung cancer will be eligible for treatment with Pfizer’s Xalkori, reversing an earlier rejection. NICE recommended ALK inhibitor Xalkori for NHS use after Pfizer agreed to markdown the drug’s price for the second time. An earlier reduction from its £51,000-a-year UK list
The FDA has approved Celltrion and Pfizer’s biosmiliar of J&J’s Remicade for treating Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriasis and arthritis of the spine. Which makes it the second biosimilar approved in the US. HyoungKi Kim, CEO of Celltrion, said that the company’s biosimilar, named Inflectra, is expected to be priced 20 to 30
Merck and Pfizer today announced that the FDA) has granted avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Breakthrough Therapy designation for the treatment of patients with metastatic Merkel cell carcinoma (MCC) that have progressed after at least one previous chemotherapy regimen. Breakthrough Therapy designation is designed to accelerate the development and review of
Pfizer is seeking approval from the US Food and Drug Administration (FDA) for its Xeljanz tablets to treat moderate-to-severe rheumatoid arthritis (RA) in patients with an inadequate response or intolerance to methotrexate (MTX).