Pfizer’s EGFR- targeting drug Vizimpro is closer to gain approval from Europe’s drug regulator authority. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has expressed a positive opinion about Vizimpro, as announced by the company. Vizimpro or dacomitinib is a single agent therapy for treating metastatic EGFR-positive non-small cell lung cancer (NSCLC). The European drug regulator has also recommended a marketing approval for the therapy in the coming weeks.
The European approval is a significant progress after the USFDA approval of the drug in September 2018. The drug has immense sales potential as EGFR-positive non-NSL cancer has low survival rates. The approval will set Vizimpro against rival drugs such as Giotrif from Boehringer Ingelheimm’s, Roche’s Tarceva, Iressa and its chief rival AZ’s Tagrisso (osimertinib). Tagrisso is being used as second-line treatment for the EGFR-mutated NSCLC and AZ is pushing for the first-line adoption.
The Vizimpro approval is another addition to Pfizer’s existing oncology pipeline portfolio. In last four months the company received FDA approval for four innovative cancer therapies which include Talzenna, a PARP inhibitor for metastatic advanced breast cancer, Lorbrena for second-line non-NSL cancer and Daurismo for untreated AML or acute myeloid leukemia.
Pfizer’s Bavencio (avelumab) is a key candidate for its oncology pipeline which is currently undergoing evaluation for different types of cancers. The drug has been approved for treating metastatic Merkell cell carcinoma in Japan, Europe and United States and has also gained FDA approval for second-line treatment of metastatic urothelial carcinoma. The approval of Bavencio for other cancer types will make it Pfizer’s long term growth driver. Pfizer is currently undertaking 30 double/triple combination studies for targeted therapies and chemotherapy and avelumab combinations with several immuno-oncology agents as part of the avelumab development program covering 15 tumor types and 9000 patients.
Pfizer’s launch of biosimilar versions of Amgen’s Epogen and Neupogen will venture the company into biosimilars space. The company is also preparing for biosimilar versions of Roche’s Rituxan, Herceptin and Avastin which are under FDA’s review process with decisions pending in late 2019. The oncology drugs sale has driven Pfizer’s profits which accounted for more than 13% of total sales in 2018. Oncology revenues rose to $7.2 billion in sales, an increase by 19% from the last year. Other Marketed drugs for cancer include Bosulif, Inlyta, Ibrance Sutent and others.