Sign in Subscribe
Pharmaceutical industry

Pfizer's XALKORI Receives US FDA Approval for Lung Cancer Treatment

Strategic Insights

— 1 min read

Pfizer Inc's innovative medication, XALKORI (crizotinib) capsules, has made a groundbreaking achievement with its approval by the US Food and Drug Administration (FDA) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive. This approval is a significant milestone, not only for Pfizer but also for the patients who will greatly benefit from this targeted therapy. The FDA approval is based on data from 255 patients across two multi-centre studies, demonstrating the efficacy of XALKORI in achieving objective response rates. This approval marks a new standard in lung cancer treatment, with XALKORI being the first therapy to target the ALK gene.

Key Takeaways:

  • The FDA has approved XALKORI (crizotinib) capsules for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is ALK-positive.
  • The approval is based on data from 255 patients across two multi-centre studies, including a Phase 2 study (PROFILE 1005) and a Part 2 expansion cohort of a Phase 1 study (Study 1001).
  • The primary efficacy endpoint in both studies was Objective Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST).
  • Pfizer worked closely with the FDA and partnered with Abbott Molecular's business to ensure the simultaneous review and approval of XALKORI along with a diagnostic test, Abbott Molecular's Vysis ALK Break Apart FISH Probe Kit.
  • This simultaneous approval marks the first time a Pfizer oncology drug or any lung cancer medication was developed and approved in parallel with a diagnostic test.
  • XALKORI is available immediately through a number of specialty pharmacies.
  • New Drug Applications for crizotinib have been filed with the Japanese Ministry of Health, Labour and Welfare, the Korean Ministry of Health, the European Medicines Agency, and the Swiss Agency for Therapeutic Products.

Statistics:

  • 255 patients participated in the studies that led to the approval of XALKORI.
  • 2 multi-centre studies were conducted to evaluate the efficacy of XALKORI.
  • 100% of patients in the studies were diagnosed with ALK-positive NSCLC.
  • 65-75% of patients achieved an objective response rate (ORR) according to RECIST criteria.
  • XALKORI is the first therapy to target the ALK gene for the treatment of NSCLC.

Sources:

  • Pfizer Inc.
  • US Food and Drug Administration (FDA)
  • Abbott Molecular's Vysis ALK Break Apart FISH Probe Kit
  • M2 Communications, August 29, 2011.

Read more