Pfizer has announced that the medicine Xalkori (crizotinib) has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for two potential treatment uses. The full article can be read here, at BusinessWire.

One is treating patients who have metastatic non-small cell lung cancer (NSCLC) with MET exon 14 alterations with disease progression on or following platinum-based chemotherapy. Xalkori has also been awarded Breakthrough Therapy designation by the FDA for treating patients who have relapsed or refractory systemic anaplastic large cell lymphoma (ALCL), which is anaplastic lymphoma kinase (ALK)-positive.

Approximately 85% of people diagnosed with lung cancer have the NSCLC form of the disease. It is challenging to treat, and often becomes metastatic (spreads to other areas of the body from where it originated). Around 3% of people diagnosed with NSCLC tumours also have MET exon 14 alterations (a type of mutation).

ALCL is a form of non-Hodgkin lymphoma and a common subtype of T-cell lymphoma. Approximately 2% of non-Hodgkin lymphomas are ALCLs, whereas 20% of all T-cell lymphomas are ALCLs. Systemic ALCL is subdivided into two forms: ALK-negative and ALK-positive.

Xalkori is a medicine that is being investigated for its usefulness for treating some patients with these conditions. The Breakthrough Therapy designations were awarded by the FDA following research into the medicine. The designation for some patients with NSCLC and MET exon 14 alterations was granted following the results of a Phase 1 study that showed Xalkori influenced anti-tumour activity. The second FDA designation for patients with relapsed or refractory systemic ALK-positive ALCL was informed by two studies (Study ADVL0912 and Study A8081013). Both showed evidence that Xalkori is involved in anti-tumour activity.

Xalkori has previously been approved for other indications. For more information about the drug, click here. The FDA’s designation of it as a Breakthrough Therapy is expected to speed up the drug development and review, partly through increased contact between the developers and the FDA. It is used for drugs that show promise for the treatment of serious diseases and may be better than existing medicines.

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