Immunotherapy Combination Induces Promising ORR in Patients With Advanced Sarcoma

February 05, 2020

The combination of talimogene laherparepvec plus pembrolizumab led to a promising objective response rate in patients with advanced sarcoma who typically have limited treatment options, according to a phase II clinical trial published in JAMA Oncology.

HER2-Directed CAR T-Cell Therapy Appears Active in Phase I Trial for Advanced Sarcoma

February 02, 2020

In an interview with Targeted Oncology, Shoba A. Navai, MD, discussed the evolving role of CAR T-cell therapy in solid tumors, including sarcomas and how the efficacy and safety compare with CAR T cells in this space compared with hematologic malignancies.

FDA Grants Accelerated Approval to Tazemetostat for Patients With Epithelioid Sarcoma

January 24, 2020

Accelerated approval has been granted by the FDA to the methyltransferase inhibitor tazemetostat for the treatment of metastatic or locally advanced epithelioid sarcoma in adult and adolescent patients who are not eligible for complete resection.

FDA Grants Fast Track Designation to LSD1 Inhibitor SP-2577 for Ewing Sarcoma

December 17, 2019

SP-2577, a potent reversible LSD1 inhibitor, has been granted Fast Track Designation by the FDA for the treatment of relapsed/refractory patients with Ewing sarcoma, Salarius Pharmaceuticals, Inc. developers of the drug, announced in a press release.

FDA Grants Regenerative Medicine Advanced Therapy Designation to ADP-A2M4 for Synovial Sarcoma

December 04, 2019

The FDA has granted a Regenerative Medicine Advanced Therapy designation to ADP-A2M4 for the treatment of patients with synovial sarcoma, according to a press release from Adaptimmune Therapeutics, developers of the agent.

FDA Grants Priority Review to Selumetinib for Neurofibromatosis Type 1 in Pediatric Patients

November 14, 2019

A New Drug Application has been accepted and granted priority review by the FDA to the investigational agent selumetinib for the treatment of patients ≥3 years old with neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas, according to a press release from AstraZeneca and Merck.

Avapritinib NDA Being Split in Two, PDGFRA+ GIST Indication Continuing Review

October 28, 2019

The FDA plans to split up the submitted New Drug Application for avapritinib into 2 separate NDAs in the treatment of 2 different populations of patients with gastrointestinal stromal tumors, according to a press release from Blueprint Medicines.

Cobimetinib Granted FDA Breakthrough Therapy Designation for Histiocytic Neoplasms

October 04, 2019

The FDA has granted cobimetinib, a MEK inhibitor, with a breakthrough therapy designation for the treatment of adult patients with histiocytic neoplasms who do not harbor a BRAF V600 mutation.

FDA Grants Breakthrough Designation to Nirogacestat for Desmoid Tumors

September 04, 2019

The FDA has granted nirogacestat, an investigational gamma-secretase inhibitor, with a breakthrough therapy designation for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis.

Ripretinib Demonstrates Benefit in Patients With Previously Treated GIST

August 13, 2019

Ripretinib demonstrated a significantly improved progression-free survival compared with placebo in patients with gastrointestinal stromal tumors being treated in the fourth-line setting or beyond, according to topline results from the phase III INVICTUS trial. An NDA for ripretinib is planned for the first quarter of 2020.