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FDA Actions & Updates
The latest approvals, designations, and new indications from the U.S. Food and Drug Administration for oncology drugs.
Tuesday, October 25, 2016

The FDA has granted Fast Track Designation for galinpepimut-S for the treatment of malignant pleural mesothelioma (MPM) patients.

Galinpepimut-S, a WT1 cancer vaccine, is a late clinical-stage immunotherapy being developed to target hematologic cancers and solid tumors, including MPM, acute myeloid leukemia, multiple myeloma, ovarian, and other cancers. A pivotal phase III trial in patients with MPM is planned in the second half of 2017.

According to phase II MPM study data of galinpepimut-S presented at the 2016 International Mesothelioma Interest Group and the ASCO 2016 Annual Meeting:

  • As of May 2016, median overall survival of 24.8 months was recorded for galinpepimut-S-treated MPM patients, compared to a median 16.6 month overall survival for patients in the control arm;
  • Patients with a complete tumor resection and subsequent treatment with galinpepimut-S showed a significant survival benefit;
  • Galinpepimut-S induced CD8+ and CD4+ T cell activation; and
  • Galinpepimut-S demonstrated a favorable safety and tolerability profile in MPM patients and was well-tolerated by patients in the trial.

Tuesday, October 25, 2016

The FDA has issued a biologics license to the Cleveland Cord Blood Center (CCBC) for Clevecord, a stem cell product (HPC, Cord Blood) derived from umbilical cord blood. Under this license, CCBC is authorized to manufacture Clevecord for use in unrelated hematopoietic cell transplantation in patients with disorders affecting the hematopoietic system such as leukemia, lymphoma, and immune system disorder.

The organization's cord blood collections represent a diverse cross-section of donor ethnicity to support transplant needs, including patients in the underserved African-American community.

"It's all about the possibility of saving lives," explained Executive Director Marcie Finney. "Our high standards are implemented from the moment the baby's cord blood is collected to the delivery of cord blood units to transplant centers. Up to 50 percent of parents giving birth in our partner hospitals donate their baby's umbilical cord blood, a rate well above the national average. "

Cleveland Cord Blood Center cord blood stem cell units are searched and accessed through registries, including the National Bone Marrow and Donor Program and Bone Marrow Donors Worldwide.

Wednesday, October 19, 2016

The FDA has modified the dosage regimen for nivolumab (Opdivo) for the currently approved indications for renal cell carcinoma, metastatic melanoma, and non-small cell lung cancer (NSCLC). The currently approved recommended dosage regimens were modified to 240 mg IV every 2 weeks.

The approval modifies the Dosage and Administration section of the labeling by replacing the single dose regimen of nivolumab (3 mg/kg IV every 2 weeks) with the new recommended regimen of

240 mg IV every 2 weeks until disease progression or intolerable toxicity for renal cell carcinoma, metastatic melanoma, and NSCLC.

In addition, the nivolumab dosing regimen in combination with ipilimumab for melanoma will remain the same (nivolumab 1 mg/kg IV, followed by ipilimumab on the same day, every 3 weeks for 4 doses). However, after completion of ipilimumab, the recommended nivolumab dose will be 240 mg every 2 weeks until disease progression or intolerable toxicity. The recommended dose for classical Hodgkin lymphoma remains 3 mg/kg IV every 2 weeks until disease progression or intolerable toxicity.

The approval was based on population pharmacokinetics analyses and dose/exposure-response analyses demonstrating the comparability of the pharmacokinetics exposure, safety, and efficacy of the proposed new dosing regimen with the previously approved regimen.

Based on simulations by the population pharmacokinetics model, FDA determined the overall exposure at 240 mg every 2 weeks flat dose is similar (less than 6% difference) to 3 mg/kg every 2 weeks. These differences in exposure are not likely to have a clinically meaningful effect on safety and efficacy, since dose/exposure response relationships appear to be relatively flat in these three indications.

Monday, October 10, 2016

The FDA has approved an Investigational Device Exemption (IDE) to evaluate the NeuroBlate System in patients newly diagnosed with glioblastoma multiforme (GBM). With this approval, the Feasibility Study on Laser Interstitial Thermal Ablation for the Treatment of Newly Diagnosed GBM (FLAG), an open-label, prospective study, will be conducted in five sites in the U.S.

The NeuroBlate System, a type of MRI-guided laser interstitial thermal therapy, is used by surgeons to destroy and coagulate soft tissue lesions in the brain. Previously, an IDE approved study was conducted to evaluate the NeuroBlate System in patients with recurrent GBM.

FLAG is designed to characterize the safety, feasibility, and effectiveness of the NeuroBlate System in combination with standard of care radiation and chemotherapy in patients with newly diagnosed GBM.

The study will enroll participants for whom a complete surgical resection is unsafe due to location, shape or size of the tumor. Overall survival, progression-free survival, patient quality of life, and healthcare utilization will be assessed during the trial in 30 patients followed for up to 12 months after the procedure and subsequent radiation and chemotherapy.

Monday, October 10, 2016

The FDA has approved a supplemental Biologics License Application for the use of ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL).

Approval for this indication by the FDA is based on results from the phase III COMPLEMENT 2 study that evaluated ofatumumab in combination with FC versus FC alone in patients with relapsed CLL.

Top-line results from COMPLEMENT 2 were reported in April 2015.

COMPLEMENT 2 is an open-label, two-arm, randomized, phase III study, which included 365 patients in 18 countries with relapsed CLL. Patients in the study were randomized 1:1 to treatment with up to six cycles of ofatumumab in combination with fludarabine and cyclophosphamide or up to six cycles with fludarabine and cyclophosphamide alone.

The study met the primary endpoint with a median progression free survival in patients receiving ofatumumab in combination with FC of 28.9 months, compared to 18.8 months in patients receiving FC alone (HR =0.67, p=0.0032). Secondary endpoints included overall response rate, overall survival, patient reported outcomes, time to response, duration of response, time to progression, time to next therapy, safety assessments, and quality of life. The safety profile observed in this study was consistent with other trials of ofatumumab and no new safety signals were observed.

Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of CLL cells and normal B lymphocytes.

In the U.S., ofatumumab is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate and for extended treatment of patients in complete or partial response after at least two lines of therapy for recurrent or progressive CLL.

About the Author

Sarah DiGiulio