FDA OK’s Roche novel therapy for non-small cell lung cancer

SWITZERLAND – Roche, a global pioneer in pharmaceuticals and diagnostics has announced that The FDA has approved Tecentriq as adjuvant treatment after surgery and platinum-based chemotherapy for adults with Stage II-IIIA non-small cell lung cancer.

The approval was based on preliminary findings from the Phase III IMpower010 study.

Following surgery and platinum-based chemotherapy, treatment with Tecentriq, or atezolizumab, reduced the risk of disease recurrence or death by 34 percent in people with Stage II-IIIA non-small cell lung cancer, compared to best supportive care.

Tecentriq has previously demonstrated clinically significant benefit in several types of lung cancer, with six currently approved indications in the United States.

Tecentriq was not only the first cancer immunotherapy approved for adjuvant non-small cell lung cancer, but it was also the first cancer immunotherapy approved for front-line treatment of adults with advanced-stage small cell lung cancer in combination with carboplatin and etoposide (chemotherapy).

Tecentriq is available in three dosing options, thus providing the flexibility to choose administration every two, three, or four weeks.

Tecentriq is also approved to treat advanced non-small cell lung cancer as a single agent or in combination with targeted therapies and/or chemotherapies in four different indications.

Too many patients with early-stage lung cancer experience disease resurgence following surgery. Now, the availability of immunotherapy following surgery and chemotherapy offers many patients new hope and powerful new tool to reduce their risk of relapse,” said Bonnie Addario, Co-founder and chair, GO2 Foundation for lung cancer.

With this approval, it is more important than ever to screen for lung cancer early and test for Programmed Death-Ligand 1 (PD-L1) at diagnosis to help bring this advance to the people who can benefit,” he added.

A PD-L1 test measures what percentage of cells in a tumor “express” PD-L1. Tumor expression of PD-L1 has been linked to a poor prognosis in a number of solid tumors, including lung cancer, and represents a validated target for immune checkpoint inhibition in advanced malignancies.

However, it is unclear whether PD-L1 can be used to predict survival in early-stage, surgically treated cancers.

Roche has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across different settings in lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers.

This includes studies evaluating Tecentriq, both alone and in combination with other medicines, as well as studies in metastatic, adjuvant, and neoadjuvant settings across various tumor types.

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