Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion for the approval of Vizimpro (dacomitinib) developed by Pfizer, Inc. for the treatment of lung cancer. Pfizer is eyeing approval of Vizimpro (45 mg) in Europe for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in patients with EGFR activating mutations. The drug was approved in the US in September 2018. The drug holds immense sales potential as EGFR-mutated non-NSCLC is associated with low overall survival rates.
Pfizer gained FDA approval for four innovative cancer medicines including Vizimpro in the last four months of 2018, which is expected to boost company’s oncology sales. The other drugs include Talzenna (talazoparib), an orally-available PARP inhibitor for advanced breast cancer, Daurismo (glasdegib) for trating acute myeloid leukemia (AML) and Lorbrena (lorlatinib) for second line non-NSCLC. Moreover, in 2017, two leukemia drugs Besponsa for relapsed/refractory acute lymphoblastic leukemia (ALL) and Mylotarg for newly diagnosed CD33-positive AML were approved in the US.
A key candidate in the oncology pipeline of the company is Bavencio (avelumab), which is being evaluated for different types of cancer. This drug is currently approved to treat metastatic Merkel cell carcinoma in the Europe, US and Japan. In the US the drug also received accelerated approval for second-line treatment of locally advanced or metastatic urothelial carcinoma. Currently, the company is also undertaking 30 studies in the avelumab development program that involves more than 9,000 patients across 15 cancer types. The studies include double/triple combination studies for chemotherapy and targeted therapies and several avelumab combination therapies with immuno-oncology agents. Pfizer has also made significant inroads in oncology biosimilars market by marketing biosimilar versions of Amgen’s AMGN drugs Neupogen and Epogen in European region and US. Biosimilar versions of Roche’s cancer drugs, Avastin, Rituxan, and Herceptin are under FDA review in the US and biosimilar Avastin and Rituxan is under review in the EU.
– Arpitha Shetty,