The FDA reviewed Tecentriq under Project Orbis, allowing the simultaneous submission and review of potential oncology treatments to international regulatory bodies.
Smith Collection_Gado_Getty Images
Genentech (Roche)’s Tecentriq has received approval from the U.S. Food and Drug Administration (FDA) as adjuvant therapy for non-small cell lung cancer (NSCLC), becoming the first in its class.
The decision is based on positive interim results from its Phase III IMpower010 study, which demonstrated a 34% improvement in disease-free survival in PD-L1-positive Stage II-III lung cancer patients, compared to the best supportive care currently available. Tecentriq, when used after surgery and platinum-based chemotherapy, lowered the risk of recurrence or death. Safety data also remained consistent throughout and no new safety signals came up.
The FDA reviewed Tecentriq under Project Orbis, allowing the simultaneous submission and review of potential oncology treatments to international regulatory bodies. Aside from the U.S., Tecentriq was submitted to Australian, Brazilian, Canadian, and UK regulators.
The U.S. FDA gave its green light under the Real-Time Oncology Review pilot program, which aims to expedite the thorough review of strong candidate therapies so that they can be made available for use as soon as possible.
Lung cancer is one of the leading causes of cancer fatalities worldwide, with around 4,900 dying daily. Of the two types of lung cancer — SCLC and NSCLC — NSCLC is the more prevalent, accounting for 85% of cases. Current treatments involve surgery, but almost 50% of such cases still experience recurrence later on.
Tecentriq has three dosage options and has four approved indications in advanced NSCLC. It can be administered every two, three, or four weeks.
“Tecentriq is now the first and only cancer immunotherapy available for adjuvant treatment of NSCLC, introducing a new era where people diagnosed with early lung cancer may have the opportunity to receive immunotherapy to increase their chances for cure,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of global product development at Roche, in a statement. Genentech is a member of the Roche Group.
“Today’s landmark approval gives physicians and patients a new way to treat early lung cancer that has the potential to significantly reduce risk of cancer recurrence, after more than a decade with limited treatment advances in this setting,” added Dr. Garraway.
NSCLC is not the only disease where Roche intends to use Tecentriq. In fact, the drug is part of a broad development program that also considers its viability as a treatment for the likes of breast, skin, lung, genitourinary, gynecological, gastrointestinal, and head and neck cancers. It is also being evaluated as a standalone treatment or in combination with our drugs, as well as in adjuvant, metastatic, and neoadjuvant settings.
In the U.S., Tecentriq is also approved to be used with Zelboraf (vemurafenib) and Cotellic (cobimetinib) to treat patients diagnosed with BRAF V600 mutation-positive advanced melanoma. It is also approved for certain types of metastatic urothelial cancer and hepatocellular carcinoma.
