JHOP Web Exclusives

The NCCN’s first guideline for side effects from immunotherapy recognizes a new spectrum of events in patients who are receiving immune checkpoint inhibitor therapy.

Chimeric antigen receptor (CAR) T-cell therapy has had excellent results in late-stage leukemia and varying degrees of success in some other hematologic cancers, but thus far, solid tumors have not responded to this therapy.

In the FDA’s dynamic regulatory environment, the patient voice has been adopted and end points for clinical trials have evolved from overall survival to other efficacy measures. “Having multiple drugs is a good thing. Many are approved on nonsurvival end points, and they have transformed the diseases,” said Richard Pazdur, MD.

New results from the phase 3 QuANTUM-R trial showed that quizartinib, an oral, selective FLT3 inhibitor, significantly extended overall survival compared with chemotherapy in patients with relapsed/refractory acute myeloid leukemia (AML) and the FLT3-ITD mutation.

This week Sellas Life Sciences Group announced data from a study of NeuVax (nelipepimut-S) in combination with Herceptin (trastuzumab) in patients with HER2 1+/2+ breast cancer.
In association with the approval of the first chimeric antigen receptor (CAR) T-cell therapy, on August 30, 2017, the FDA also accelerated the approval of a new indication as an orphan drug for toci­lizumab.
On September 1, 2017, the FDA approved gemtuzumab ozogamicin (Mylotarg; Pfi­zer) for the treatment of adults with newly diagnosed CD33-positive acute myeloid leukemia (AML), as well as patients aged ≥2 years with relapsed or refractory CD33-positive AML. It is approved as an orphan drug for this indication.
On July 31, 2017, the FDA accelerated the approval of a new indication for nivolumab (Opdivo; Bristol-Myers Squibb) for the treatment of patients aged ≥12 years with mismatch repair–deficient (dMMR) and microsatellite instability–high (MSI-H) metastatic colorectal cancer (CRC) that progressed after treatment with fluoropyrimidine, oxaliplatin, and irinotecan.
On August 17, 2017, the FDA approved inotuzumab ozogamicin (Besponsa; Pfi­zer), a targeted therapy, for the treatment of adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). The drug blocks cancer growth by binding to B-cell ALL cells that express CD22. The FDA designated inotuzumab ozogamicin as an orphan drug and applied its priority review for this approval.
On August 30, 2017, the FDA approved tisagenlecleucel (Kymriah; Novartis Pharmaceuticals), a genetically modified chimeric antigen receptor (CAR) T-cell immunotherapy, for the treatment of pediatric patients and young adults aged ≤25 years with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL).
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