FDA approves Genentech’s first-line NSCLC chemotherapy treatment

 


	FDA grants approval for Genentech’s Tecentriq – Chemotherapy combination treatment, based on positive results from Phase III Impower130 trial
	The combination is designed to be used as a first-line treatment for metastatic non-squamous non-small cell lung cancer or NSCLC.


Cancer is one of the leading causes for concern in the global healthcare sector. In fact, the American Cancer Society has estimated that over 228,000 U.S residents will suffer from lung cancer in 2019, with NSCLC accounting for nearly 80-85% of all lung cancer diagnoses. In light of these alarming numbers, the pharmaceutical sector is rallying to develop effective treatment solutions for this severe ailment.

One such entity is Roche Group member Genentech. The U.S-based biotechnology firm has recently announced the approval of its Tecentriq® and chemotherapy combination treatment by the U.S Food & Drug Administration. The combination of Tecentriq® (atezolizumab) and chemotherapy (carboplatin and Abraxane) is developed to be the initial or first-line treatment for patients suffering from metastatic NSCLC or non-squamous non-small cell lung cancer, without ALK or EGRF genomic tumor aberrations.

Chief Medical Officer and Head of Global Product Development, Dr. Levi Garraway, M.D., Ph.D., has reportedly stated that the Tecentriq-based combination treatment will offer clinically significant survival benefits for NSCLC patients. He expressed his elation at the FDA approval, claiming that this certification would help present new horizons and prolonged lives for people suffering from the disease.

The basis for the FDA approval is the results of the Phase III Impower130 study for Tecentriq combined with chemotherapy, which revealed that patients receiving this combination treatment observed significantly prolonged life cycles in the intention-to-treat wild-type (ITT-WT) population as compared to those treated with chemotherapy alone. The Tecentriq-chemotherapy combination also demonstrated a considerably high reduction in risk of disease worsening or death compared to only chemotherapy in ITT-WT population.

The Tecentriq – chemotherapy combination safety also appeared to be consistent with the established safety profiles of the medicines individually and revealed no new safety signals with the combination.

Genentech has an extensive development plan for Tecentriq in place, with nine Phase III studies in progress, across myriad lung cancer types, in addition to a multitude of planned and ongoing Phase III trials for skin, breast, genitourinary, head, neck, gynecological and gastrointestinal cancers.

Source Credits: https://www.gene.com/media/press-releases/14827/2019-12-03/fda-approves-genentechs-tecentriq-plus-c