fda update

On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to bosutinib (Bosulif®, Pfizer Inc.) for treatment of patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML).

Approval was based on data from an open-label, randomized, multicenter trial (BFORE, NCT02130557) in 487 patients with Ph+ newly-diagnosed CP CML who were randomized to receive either bosutinib 400 mg once daily or imatinib 400 mg once daily. The major efficacy outcome measure was major molecular response (MMR) at 12 months, defined as ≤0.1% BCR‑ABL ratio on international scale (corresponding to ≥3 log reduction from standardized baseline) with a minimum of 3000 ABL transcripts as assessed by the central laboratory. MMR at 12 months was 47.2% (95% CI: 40.9, 53.4) in the bosutinib arm and 36.9% (95% CI: 30.8, 43.0) in the imatinib arm (p=0.0200).

Most common adverse reactions in patients with newly-diagnosed CML (incidence ≥20%) are diarrhea, nausea, thrombocytopenia, rash, increased alanine aminotransferase, abdominal pain, and increased aspartate aminotransferase.

FDA first approved bosutinib in 2012 for treatment of patients with chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy.

The recommended dose of bosutinib for newly-diagnosed chronic phase Ph+ CML is 400 mg orally once daily with food.

Full prescribing information is available.

FDA granted priority review and Orphan Drug designation to bosutinib for this application. As a condition of accelerated approval, further follow-up of patients in the BFORE trial is required. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

Follow the Oncology Center of Excellence on Twitter @FDAOncology.

Check out recent approvals at the OCE’s podcast, Drug Information Soundcast in Clinical Oncology (DISCO).

In collaboration with the FDA and as a service to our members, ONS provides updates on recent FDA approvals and other important FDA actions (e.g., updated safety information, new prescribing information) pertaining to therapies for patients with cancer. This allows the agency to inform oncologists and professionals in oncology-related fields in a timely manner. Included in the FDA updates is a link to the product label or to other sites for additional relevant clinical information. In supplying this information, ONS does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described.

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