Pfizer's (PFE) New Lung Cancer Drug Vizimpro Gets CHMP Nod

Pfizer, Inc. (NYSE:PFE) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion, recommending marketing approval of its new lung cancer medicine, Vizimpro (dacomitinib).

Pfizer is eyeing approval of Vizimpro (45 mg), an EGFR tyrosine kinase inhibitor, in Europe for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in patients with EGFR activating mutations. The CHMP’s decision will now be reviewed by the European Commission, which mostly follows the same.

Vizimpro was approved in the United States in September last year. The drug holds immense sales potential as EGFR-mutated non-NSCLC is a disease that is associated with low overall survival rates.

Pfizer is making significant progress in its oncology pipeline portfolio. Inthe last four months of 2018, Pfizer gained FDA approval for four innovative cancer medicines including Vizimpro, which may boost its oncology sales. These include Daurismo (glasdegib) for previously untreated acute myeloid leukemia (AML), Lorbrena (lorlatinib) for second line non-NSCLC and Talzenna (talazoparib), an orally-available PARP inhibitor for advanced breast cancer.

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 in the United States, Europe and Japan. It also received accelerated approval for second-line treatment of locally advanced or metastatic urothelial carcinoma in the United States. Bavencio, though approved for two small indications currently, is being considered 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. Pfizer has developed Bavencio in partnership with Germany’s Merck KGaA MKGAF.

Pfizer is also venturing into the oncology biosimilars space. In Europe and United States, Pfizer markets biosimilar versions of Amgen’s (NASDAQ:AMGN) drugs Neupogen and Epogen. Biosimilar versions of Roche’s (OTC:RHHBY) cancer drugs, Rituxan, Avastin (trade name: Zirabev) and Herceptin are under review in the United States with FDA decisions on all expected in 2019. A biosimilar version of Herceptin was approved in the EU in July 2018 while that of biosimilar Rituxan and Avastin is under review in the EU.

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 19% to $7.2billion. 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’s shares have risen 23.7% in the past year compared with an increase of 7.1%for the industry.

Pfizer currently carries a Zacks Rank #4 (Sell).

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