Blincyto Receives Expanded Indication to Include Patients with Ph+ B-Cell Precursor ALL

Web Exclusives - FDA Approvals, News & Updates, Web Exclusive

On July 11, 2017, the FDA approved an expanded indication for blinatumomab (Blincyto; Amgen) to include the treatment of patients with Philadelphia chromosome (Ph)-positive (Ph+), relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

This current regular FDA approval also provides confirmation of the 2014 accelerated approval granted to blinatumomab for the treatment of patients with Ph-negative relapsed or refractory B-cell precursor ALL. It also expands the indication to include all patients with relapsed or refractory B-cell precursor ALL, regardless of their Ph chromosome status.

The study that confirmed the initial approval was based on TOWER, a randomized clinical trial that compared blinatumomab and standard-of-care chemotherapy in 405 patients with relapsed or refractory B-cell precursor ALL. Results showed significant improvement in overall survival (OS) with blinatumomab versus chemotherapy (hazard ratio, 0.71; P = .012); the estimated median OS was 7.7 months versus 4.0 months, respectively.

The expanded indication to patients with Ph+ disease was based on ALCANTARA, a single-arm multicenter study of 45 patients with Ph+ relapsed or refractory with relapsed or refractory B-cell precursor ALL. Overall, 36% of patients reached complete remission with blinatumomab, with a median remission duration of 6.7 months.

The 2 studies did not report any new major adverse events.

Related Items
Oncology Drugs Approved by the FDA in Early 2018
June 2018 Vol 11, No 4 published on June 25, 2018 in FDA Approvals, News & Updates
Welcome to the Ninth Annual Payers’ Guide to New FDA Approvals
March 2018, Vol 11, Ninth Annual Payers' Guide published on April 12, 2018 in FDA Approvals, News & Updates
FDA Approvals in 2017 Represent a 21-Year High
Gary M. Owens, MD
March 2018, Vol 11, Ninth Annual Payers' Guide published on April 11, 2018 in FDA Approvals, News & Updates
FDA Approvals of Brand-Name Prescription Drugs in 2017
March 2018, Vol 11, Ninth Annual Payers' Guide published on April 11, 2018 in FDA Approvals, News & Updates
Bavencio (Avelumab) Approved for Metastatic Merkel-Cell Carcinoma and for Urothelial Carcinoma
Lisa A. Raedler, PhD, RPh
March 2018, Vol 11, Ninth Annual Payers' Guide published on April 10, 2018 in FDA Approvals, News & Updates
Last modified: August 10, 2017
  •  Association for Value-Based Cancer Care
  • Value-Based Cancer Care
  • Value-Based Care in Rheumatology
  • Oncology Practice Management
  • Rheumatology Practice Management
  • Urology Practice Management
  • Inside Patient Care: Pharmacy & Clinic
  • Lynx CME