Crizotinib FDA approval benefits ALK-positive NSCLC patients

Crizotinib FDA approval benefits ALK-positive NSCLC patients

crizotinibOn November 21, 2013 the FDA announced the approval of the formidable cancer drug Crizotinib to treat ALK-positive tumors. Patients with metastatic non-small cell lung cancer who have anaplastic lymphoma kinase (ALK)-positive tumors stand to benefit greatly from the Crizotinib FDA approval.  Encouraging data that demonstrated efficacious progression-free survival propelled the Crizotinib FDA approval decision. In 2011 the FDA granted an accelerated approval of Crizotinib based on positive data from two single-arm studies.

The latest trial which led to the approval of this effectual cancer treatment involved 347 patients with unresectable non-small cell lung cancer {NSCLC} that was ALK positive. The trial was an active controlled, randomized and multinational study. Patients in this study received  250 milligrams of oral Crizotinib twice a day or best in care chemotherapy. Results revealed a significant rate of prolonged progression-free survival for the patients who were administered with Crizotinib, with roughly 7.7 months additional time. The adverse effects of Crizotinib effected roughly one quarter of the patient population, and including diarrhea, nausea, vomiting, fatigue and edema.

Pfizer markets the brand for Crizotinib, coined Xalkori. The patent for Pfizer is valid until March 2025. Rates of NSCLC are on the rise worldwide, and growing in number sizably in the United States. Roughly 1 in every 13 men and 1 in every 16 women in the U.S. are diagnosed with NSCLC every year. While this deadly disease primarily affects smokers, the rates of non-smokers being diagnosed with non-small cell lung cancer are increasing. According to Formulary Online NSCLC represents 85 percent of the lung cancer patient population. Patients who receive a non-small cell lung cancer diagnosis are offered an FDA approved diagnostic test, created by Abbott Laboratories, which will determine if they have the ALK gene variant.

LGM Pharma provides API  Crizotinib, CAS # 877399-52-5,  for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.


Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

  • Share:

LGM Pharma Acquires CDMO

On July 27, 2020, LGM Pharma announced its acquisition of the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. As a result, you will notice our new logo and visuals throughout the website. We’re working on updates to reflect the exciting, expanded CDMO capabilities and services we now can offer you.

This website uses cookies. By using our site, you agree to our terms of service