Pfizer, Inc. PFE announced that the European Commission has granted marketing approval to its tyrosine kinase inhibitor, Vizimpro (dacomitinib) for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in patients with EGFR activating mutations. This new lung cancer medicine was approved in the United States last September.
Vizimpro’s (45 mg)approval in EU was expected as in February the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had granted a positive opinion recommending approval of Vizimpro. The drug holds immense sales potential as EGFR-mutated NSCLC is a disease that is associated with low overall survival rates.
Including Vizimpro, in oncology, Pfizer gained FDA approval for four innovative medicines in the last four months of 2018, which has strengthened its oncology portfolio. These include Daurismo (glasdegib) for previously untreated AML, Lorbrena (lorlatinib) for second line non-small-cell lung cancer and Talzenna (talazoparib), an orally-available PARP inhibitor for advanced breast cancer.
Shares of Pfizer have declined 1.8% so far this year against the industry’s 4.8% increase.
Moreover, two leukemia treatments — Besponsa/inotuzumab ozogamicin for relapsed/refractory acute lymphoblastic leukemia (ALL) and Mylotarg for newly diagnosed CD33-positive AML — were approved in the United States in 2017.
A key candidate in the oncology pipeline is Bavencio (avelumab), which is being evaluated for different types of cancer. Bavencio is already approved in metastatic Merkel cell carcinoma and for second-line treatment of locally advanced or metastatic urothelial carcinoma. Bavencio, though approved for two small indications currently, could be a key long-term growth driver for Pfizer if it can gain label expansion approvals.
Pfizer has 30 ongoing studies in the avelumab development program involving more than 9,000 patients across 15 tumor types. The studies include double/triple combination studies for chemotherapy and targeted therapies and several avelumab combination therapies with immuno-oncology agents are under development. Pfizer has developed Bavencio in partnership with Germany’s Merck KGaA MKGAF.
Pfizer is als oventuring into the oncology biosimilars space. In Europe and United States, Pfizer markets biosimilar versions of Amgen’s AMGN drugs, Neupogen and Epogen. A biosimilar version of Roche’s RHHBY cancer drug Herceptin (trade name: Trazimera) was approved by the FDA in March. Biosimilar versions of Roche’s other cancer drugs Rituxan and Avastin (trade name: Zirabev) are also under review in the United States with FDA decisions on all expected in 2019. Biosimilar versions of Herceptin and Avastin are already approved in the EU while that of Rituxan is under review in the EU. Pfizer is evaluating several biosimilar molecules in various stages of development.
In fact, oncology drugs have been a key driver of Pfizer’s sales, accounting for more than 13% of its total sales in 2018. Oncology revenues increased 30% to $1.91 billion in 2018. Its marketed oncology drugs are Ibrance Sutent, Inlyta, Bosulif and others. Pfizer also gets a share of profit from its alliance with Japan’s Astellas Pharma for Xtandi.
Pfizer currently carries a Zacks Rank #3 (Hold).
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