FDA Approves Tagrisso (Osimertinib) for Non-Small Cell Lung Cancer

The US Food and Drug Administration (FDA) has approved Tagrisso (osimertinib) to treat people with a type of advanced non-small cell lung cancer. It’s for lung cancers with a specific epidermal growth factor receptor (EGFR) mutation called T790M that have gotten worse after treatment with other EGFR-blocking drugs.

Some lung cancer cells to have too much of the EGFR protein, which leads them to grow faster. EGFR-blocking drugs work by interrupting the signal from the protein that tells cells to grow. But these drugs tend to stop working over time, often as the result of new mutations in the EGFR gene, such as the T790M mutation. Tagrisso is a newer type of EGFR-blocking drug that also works against cells with the T790M mutation.

Along with approving the new drug, the FDA approved a companion test designed to detect the T790M mutation.

The FDA based its approval of Tagrisso – formerly called AZD9291 – on 2 studies involving 411 people with advanced non-small lung cancer driven by the T790M mutation, whose cancer had gotten worse after previous treatment with an EGFR-blocking drug. Tumors disappeared or shrank in 57% of participants in the first study and 61% of participants in the second study.

Tagrisso was approved using several FDA approaches designed to speed up the availability of drugs to treat serious diseases – breakthrough therapy designation, priority review, and accelerated approval. It was also granted orphan drug designation, which provides financial incentives to encourage the development of drugs for rare diseases.

The most common side effects of Tagrisso are diarrhea, skin and nail conditions such as dry skin, rash and infection or redness around the fingernails. Tagrisso may cause serious side effects, including inflammation of the lungs and injury to the heart. It also may cause harm to a developing fetus.

Tagrisso is marketed by Astra Zeneca Pharmaceuticals. The cobas EGFR Mutation Test v2 is marketed by Roche Molecular Systems.


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