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

Web Exclusives - FDA Approvals, News & Updates

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
April 16, 2019 – FDA Approvals, News & Updates
Web Exclusives published on April 16, 2019 in FDA Approvals, News & Updates, In the News
Copiktra (Duvelisib) Approved for 3 Types of Relapsed or Refractory Leukemia
March 2019, Vol 12, Tenth Annual Payers' Guide published on April 16, 2019 in Drug Updates, Web Exclusives, FDA Approvals, News & Updates
Lorbrena (Lorlatinib) Approved for the Treatment of Metastatic Non–Small-Cell Lung Cancer with ALK Mutation
March 2019, Vol 12, Tenth Annual Payers' Guide published on April 16, 2019 in Drug Updates, Web Exclusives, FDA Approvals, News & Updates
Lutathera (Lutetium Lu 177 Dotatate) First Radioactive Drug Approved for Gastroenteropancreatic Neuroendocrine Tumors
March 2019, Vol 12, Tenth Annual Payers' Guide published on April 16, 2019 in Drug Updates, Web Exclusives, FDA Approvals, News & Updates
Vizimpro (Dacomitinib) Approved for First-Line Treatment of Metastatic Non–Small-Cell Lung Cancer with EGFR Mutation
March 2019, Vol 12, Tenth Annual Payers' Guide published on April 16, 2019 in Drug Updates, Web Exclusives, FDA Approvals, News & Updates
Last modified: August 10, 2017
  •  Association for Value-Based Cancer Care
  • Oncology Practice Management
  • Value-Based Cancer Care
  • Value-Based Care in Rheumatology
  • Rheumatology Practice Management
  • Urology Practice Management
  • Lynx CME