Tag Archives: Xalkori

May, 2018

31 May
FDA Grants Breakthrough Therapy Designation to Pfizer’s Xalkori for Two New Indications

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for XALKORI® (crizotinib) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with MET exon 14 alterations with disease progression on or after platinum-based chemotherapy. The FDA also …
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7 November
Roche’s VENTANA ALK (D5F3) CDx Assay Receives FDA Approval

TUCSON, Ariz., Nov. 7, 2016 /PRNewswire/ — Roche (SIX: RO, ROG; OTCQX:RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved the VENTANA ALK (D5F3) CDx Assay1 for use on the VENTANA BenchMark ULTRA automated slide stainer. The assay is a companion diagnostic to aid in the …
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11 March
FDA Expands Approval of Pfizer’s Xalkori to Treat a Rare Form of Advanced NSCLC

Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for XALKORI® (crizotinib) to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. In 2015, the FDA granted Breakthrough Therapy and Priority Review designations for this …
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9 December
FDA Grants Priority Review for Pfizer’s Xalkori in NSCLC

Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for a supplemental New Drug Application (sNDA) for XALKORI® (crizotinib) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. In April 2015, XALKORI received Breakthrough …
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21 April
Pfizer’s Antibody-Drug Conjugate Succeeds in Phase 3 Study and its Xalkori Receives Breakthrough Therapy Designation

Pfizer Inc. announced positive news for two of its cancer drugs today. The company said that US health regulators granted its Xalkori (crizotinib) Breakthrough Therapy designation, and, separately, Pfizer announced that its investigational antibody-drug conjugate (ADC) met one of its main goals in a late-stage leukemia trial. The US Food …
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