Roche receives FDA approval for VENTANA ALK (D5F3) CDx Assay to identify lung cancer patients eligible for targeted treatment with LORBRENA (lorlatinib)

  • About 235,000 people in the US will be diagnosed with lung cancer in 2021, with non-small cell lung cancer (NSCLC) accounting for 84 percent of all lung cancers1
  • ALK — anaplastic lymphoma kinase — is an important biomarker found in NSCLC, and targeted therapies have been shown to dramatically improve progression-free survival compared to the previous standard of care2,3,4
  • The VENTANA ALK (D5F3) CDx Assay5 is now FDA approved as a companion diagnostic in four targeted treatments, providing more options to lung cancer patients

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C-Path Receives FDA Qualification for the Diary for Irritable Bowel Syndrome Symptoms-Constipation (DIBSS-C)

TUCSON, Ariz., March 9, 2021 — Critical Path Institute’s (C-Path) Patient-Reported Outcome (PRO) Consortium announces the qualification of the Diary for Irritable Bowel Syndrome Symptoms-Constipation (DIBSS-C) by the U.S. Food and Drug Administration (FDA). The DIBSS-C was developed by the PRO Consortium’s Irritable Bowel Syndrome (IBS) Working Group to support symptom-based efficacy endpoints in clinical trials for products intended to treat constipation-predominant IBS (IBS-C) in adults. Qualification of the DIBSS-C represents a major milestone for the IBS Working Group and is the PRO Consortium’s fourth clinical outcome assessment (COA) to be qualified through the COA Qualification Program within FDA’s Center for Drug Evaluation and Research.Continue reading