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AstraZeneca’s non-small lung cancer therapy gets FDA clearance

The USFDA has cleared AstraZeneca’s lung cancer drug Tagrisso with chemotherapy for treatment in adult patients.

HQ Team

February 17, 2024: The USFDA has cleared AstraZeneca’s Tagrisso with chemotherapy for treatment in adult patients with non-small cell lung cancer.

The approval came after a priority review by the US drug regulator and was based on final clinical trials.

The drug, with the chemotherapy combination, cut the risk of disease progression by 38% compared to Tagrisso alone, according to an AstraZeneca statement.

The trial enrolled 557 patients in more than 150 centres across 20 countries, including in the US, Europe, South America and Asia.

Most common

More than 200,000 people are diagnosed with lung cancer, and 80-85% of these patients are diagnosed with non-small cell lung cancer (NSCLC) — the most common form of lung cancer.

About 70% of people are diagnosed with advanced NSCLC. Additionally, about 15% of NSCLC patients in the US have a mutation in the gene that makes a protein that is involved in cell growth and cell survival.

The epidermal growth factor receptor gene mutation may cause cancer cells to grow and spread in the body.  Checking for changes in the gene in tumour tissue may help plan cancer treatment.

AstraZeneca’s treatment option “can delay disease progression by nearly nine additional months, establishing a new benchmark with the longest reported progression-free survival benefit in the first-line advanced setting,” said Pasi A. Jänne, MD, PhD, medical oncologist at Dana-Farber Cancer Institute and principal investigator for the trial.

Safety profile

The safety profile of Tagrisso (osimertinib) with the addition of chemotherapy was generally manageable and consistent with the established profiles of the individual medicines, according to the statement.

Adverse event rates were higher in the Tagrisso plus chemotherapy arm, “driven by well-characterised chemotherapy-related adverse events.”

Laurie Ambrose, President and CEO, of GO2 for Lung Cancer, said: “The more we can target the right treatments for the right people at the right time, the better outcomes will be for our community – a goal we all collectively share.”

Project Orbis

The US regulatory submission was reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners.

As part of Project Orbis, Tagrisso in combination with chemotherapy is also under review by regulatory authorities in Australia, Canada, and Switzerland. 

Regulatory applications are also under review in several other countries. The drug is approved as a monotherapy in more than 100 countries including the US, EU, China and Japan.


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