Cranbury, NJ—This week, the U.S. Food & Drug Administration (FDA) has announced multiple new approvals or indications in the fields of hematology and oncology.
1. Inotuzumab ozogamicin approved for relapsed or refractory ALL On Thursday, August 17, the FDA approved the use of inotuzumab ozogamicin, an antibody-drug conjugate, for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) to Pfizer, Inc. Inotuzumab ozogamicin is a targeted therapy that is thought to work by binding to CD22 antigen expressing B-cell ALL cancer cells, blocking their growth.
The safety and efficacy of inotuzumab ozogamicin were evaluated in the phase 3 INO-VATE ALL trial (NCT01564784), an randomized, open-label trial, reported in the New England Journal of Medicine in August of last year. Three hundred twenty-six (326) patients were randomized to receive inotuzumab ozogamicin or investigator’s choice chemotherapy. Complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) rates were significantly higher in patients receiving inotuzumab ozogamicin than in the standard-therapy group, 80.7% versus 29.4%. Duration of remission was also longer in patients receiving inotuzumab ozogamicin, 4.6 months versus 3.1 months for patients receiving standard chemotherapy. Median overall survival was 7.7 months and 6.7 months for patients receiving inotuzumab ozogamicin and standard chemotherapy, respectively. The most common grade 3 or higher adverse events for patients receiving inotuzumab ozogamicin were liver-related, the most common being veno-occlusive disease (VOD).
2. Olaparib tablet formulation approved for ovarian cancer maintenance therapy Also on Thursday, the FDA granted regular approval to a new olaparib formulation for the maintenance treatment of adults patients experiencing recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are currently in a complete or partial response to platinum-based chemotherapy. This approval is based on the results of the phase 3 SOLO-2 (NCT01874353) and phase 2 Study 19 (NCT00753545) trials.
In SOLO-2, 295 patients with recurrent germline BRCA-mutated ovarian, fallopian tube, or primary peritoneal cancer were randomized (2:1) to receive olaparib tablets 300 mg orally twice daily or a placebo. SOLO-2 demonstrated a statistically significant improvement in progression-free survival (PFS). The estimated median PFS was 19.1 versus 5.5 months in patients receiving olaparib and placebo, respectively.
In Study 19, 265 patients with platinum-sensitive, recurrent high-grade serous ovarian cancer, regardless of BRCA status, were randomized (1:1) to receiving olaparib capsules 400 mg twice daily or a placebo. Study 19 also demonstrated a statistically significant improvement in PFS. The estimated median PFS was 8.4 months versus 4.8 months in patients receiving olaparib and placebo, respectively. In both trials, the most common adverse events included anemia, nausea, fatigue, vomiting, diarrhea, headache, dyspepsia, decreased appetite, constipation, etc.
Please visit the FDA’s website for more information on this approval.--
Published Online: Friday August 18, 2017