FDA approves Tecentriq for new lung cancer indication

 

The U.S. Food and Drug Administration (FDA) approved Genentech’s Tecentriq plus chemotherapy as a first-line treatment of metastatic non-squamous non-small cell lung cancer. The approval is for patients who have no EGFR or ALK genomic tumor aberrations.

Approval for Tecentriq (atezolizumab) was based on the Phase III IMpower130 study that showed Tecentriq plus chemotherapy combination demonstrated a significant overall survival and progression-free survival benefit. Trial patients on the Genentech therapy showed a median overall survival of 18.6 months versus 13.9 months. Progression-free survival also was boosted in the study, with patients having a median of 7.2 months versus 6.5 months.

Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination, Genentech said.

Levi Garraway, chief medical officer and head of Global Product Development for Genentech, said the new treatment combination can provide a clinically meaningful survival benefit for people with non-squamous non-small cell lung cancer. The approval, he added, provides an additional treatment option that can prolong the lives of people with this type of the disease.

The latest approval for Tecentriq moves the medical community one step closer to the goal of finding a treatment option for every person with lung cancer, Genentech said. The latest approval comes about eight months after the FDA approved Tecentriq in combination with chemotherapy (carboplatin and etoposide) for the initial treatment of adults with extensive-stage small-cell lung cancer. That approval marked the first immunotherapy approved in the U.S. as an initial treatment for extensive-stage small cell lung cancer, and the first new initial treatment for this tough-to-treat cancer in 20 years. 

That first-of-its-kind approval in March was the preceded only days before by another approval. The FDA approved Tecentriq plus chemotherapy for the treatment of adults with PD-L1-positive, metastatic triple-negative breast cancer. In that case, Tecentriq was granted accelerated approval based on progression-free survival.  

Genentech has an extensive development program for Tecentriq, including nine Phase III studies underway across different types of lung cancer, and multiple ongoing and planned Phase III studies across genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

According to the American Cancer Society, it is estimated that more than 228,000 Americans will be diagnosed with lung cancer in 2019. Non-Small Cell Lung Cancer accounts for 80-85% of all lung cancers. It is estimated that approximately 60% of lung cancer diagnoses in the United States are made when the disease is in the advanced stages.