FDA approves Roche's companion diagnostic for Pfizer's non-small cell lung cancer med

The molecular location on chromosome 2 of the ALK gene--Courtesy of the NIH's U.S. National Library of Medicine

Roche's ($RHHBY) Ventana Medical Systems has just received FDA approval of its Ventana ALK (DF53) as a companion diagnostic for Pfizer's ($PFE) Xalkori to treat non-small cell lung cancer.

The companion diagnostic tests for the anaplastic lymphoma kinase (ALK) fusion gene, which is associated with expression of the ALK pathologic fusion protein. Inhibition of the protein by oral administration of Xalkori can lead to tumor shrinkage in ALK-positive patients, Roche says.

The ALK gene and protein is believed to assist in the proliferation of nerve cells early in development by transmitting signals from a cell's surface to its interior.

The National Institutes of Health explains the science behind ALK's association with NSCLC, saying that a small group of people with disease have an inversion on the gene's chromosome that fuses ALK gene with the gene for another protein. The resulting creation of a fusion protein (dubbed EML4-ALK), "may abnormally increase the proliferation of immature nerve cells, leading to cancer formation."

"The test provides physicians and patients a fast and accurate method to identify ALK protein expression, and clinicians can be confident knowing that our FDA approval is based on data resulting from collaboration between Ventana and Pfizer. Ventana used the Ventana ALK (D5F3) companion diagnostic assay and scoring method to retrospectively test patient samples from Pfizer-sponsored clinical trials and demonstrated that the test is effective in identifying patients with ALK-positive NSCLC who may benefit from treatment with Xalkori" said Dr. Mary Padilla, senior director of pathology and medical director for Ventana Companion Diagnostics, in a statement.

Ventana says the companion diagnostic will enable patient to learn their ALK mutation status in days instead of weeks.

Companion diagnostics are the cornerstone of personalized medicine because they enable doctors to give patients the treatment they are most likely to respond to based on biomarkers like the patient's genetic status or disease subtype.

The FDA approval comes on the heels of agency's approval of Ventana's companion diagnostic for the KRAS mutation, which is needed needed to identify metastatic colorectal cancer patients without the mutation, for whom treatment with Eli Lilly's ($LLY) Erbitux or Amgen's ($AMGN) Vectibix may be effective.

In April, Ventana announced a companion diagnostic agreement centered around Astellas Pharma's cancer-fighting candidate, ASP5878.

And in January, Roche said it will shell out $1 billion plus milestone payments for a majority share in Foundation Medicine, further bolstering its diagnostics offerings for cancer.

- read the release

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