FDA Grants Regenerative Medicine Advanced Therapy Designation to ADP-A2M4 for Synovial Sarcoma
December 4th 2019The 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.
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FDA Grants Priority Review to Selumetinib for Neurofibromatosis Type 1 in Pediatric Patients
November 14th 2019A 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.
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Avapritinib NDA Being Split in Two, PDGFRA+ GIST Indication Continuing Review
October 28th 2019The 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.
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Cobimetinib Granted FDA Breakthrough Therapy Designation for Histiocytic Neoplasms
October 4th 2019The 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 <em>BRAF</em> V600 mutation.
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FDA Grants Breakthrough Designation to Nirogacestat for Desmoid Tumors
September 4th 2019The 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.
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Ripretinib Demonstrates Benefit in Patients With Previously Treated GIST
August 13th 2019Ripretinib 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.
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FDA Grants Priority Review to Avapritinib in PDGFRA+ and Fourth-Line GIST
August 7th 2019The FDA has granted a priority review to a New Drug Application for avapritinib as a treatment for adult patients with <em>PDGFRA</em> exon 18–mutant gastrointestinal stromal tumors, regardless of prior therapy, and in the fourth-line setting for GIST.
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Tazemetostat Receives FDA Priority Review for Metastatic or Locally Advanced Epithelioid Sarcoma
July 25th 2019A new drug application for tazemetostat, an EZH2 inhibitor, has been granted a priority review by the FDA for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery based on data from the epithelioid sarcoma cohort of a phase II trial.
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VEGFR Targeted Therapies and Combinations Emerge for the Treatment of Sarcomas
July 2nd 2019Based on the ongoing and positive data observed with VEGFR targeted therapies, novel tyrosine kinase inhibitors and those already approved for other disease indications may become available to patients with bone and soft tissue sarcomas.
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Tazemetostat Submitted for FDA Approval in Epithelioid Sarcoma
May 31st 2019A new drug application for tazemetostat was submitted to the FDA for the treatment of patients with epithelioid sarcoma who are not eligible for curative surgery, according to Epizyme, the manufacturer of the EZH2 inhibitor.
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Pexidartinib Supported by FDA's ODAC for Tenosynovial Giant Cell Tumors
May 14th 2019A scheduled meeting of the FDA's Oncologic Drugs Advisory Committee supported the indication of pexidartinib as a treatment for adult patients with symptomatic tenosynovial giant cell tumor. The panel voted 12 to 3 in favor of the CSF1R inhibitor.
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Pomalidomide Receives FDA Breakthrough Designation for Kaposi Sarcoma
May 13th 2019Pomalidomide was granted a breakthrough designation by the FDA for use as treatment for both patients with HIV-positive Kaposi sarcoma who have had prior chemotherapy and patients with HIV-negative Kaposi sarcoma.
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Olaratumab to Be Withdrawn From Market for Soft Tissue Sarcoma After Missing Primary Endpoint
April 30th 2019The PDGFRα antagonist olaratumab (Lartruvo) will be withdrawn from the market for the treatment of patients with advanced soft tissue sarcoma due to disappointing findings in the phase III ANNOUNCE trial, according to Eli Lilly and Company.
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MEK Inhibitor Granted Breakthrough Designation for NF1 Plexiform Neurofibromas
April 1st 2019The FDA has granted a breakthrough therapy designation to the investigational agent selumetinib for the treatment of pediatric patients ≥3 years old with symptomatic and/or progressive, inoperable neurofibromatosis type 1
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CAR T-Cell Therapy and Lymphodepletion Demonstrates Early Activity in Advanced Sarcoma
April 1st 2019In phase I findings presented during the 2019 AACR Annual Meeting, HER2-directed CAR T-cell therapy and lymphodepletion chemotherapy was found to be safe and effective as a treatment for pediatric and adult patients with advanced HER2-positive sarcoma.
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Positive Correlation With Patient-Reported Outcomes Seen in Phase III ENLIVEN Trial
January 24th 2019Hans Gelderblom, MD, PhD, discusses the correlation between the overall response rate by Tumor Volume Score and RECIST 1.1 criteria in patients with advanced tenosynovial giant cell tumors treated with pexidartinib.
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Olaratumab Combination Misses OS Endpoint for Sarcoma in Phase III Trial
January 23rd 2019The primary endpoint of overall survival benefit with the combination of olaratumab plus doxorubicin was not met for patients with advanced or metastatic soft tissue sarcoma in the phase III ANNOUNCE clinical trial.
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Abemaciclib Demonstrates Promising Clinical Activity in Dedifferentiated Liposarcoma
November 20th 2018Results from a phase II trial of abemaciclib presented at the 2018 CTOS Annual Meeting showed that the majority of patients with dedifferentiated liposarcoma remained progression free at 12 weeks following abemaciclib treatment.
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Olaratumab Added to Doxorubicin-based Chemo May Improve Safety in Select Patients With Advanced STS
November 20th 2018The addition of olaratumab to doxorubicin-based chemotherapy resulted in similar response and stable disease rates between patients with advanced soft tissue sarcoma and a good performance status, but provided an improved safety profile that favored the olaratumab cohort, according to results reported at the 2018 CTOS Annual Meeting.
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Avapritinib Demonstrates Potentially Practice Changing Results in GIST
November 19th 2018Avapritinib showed substantial clinical activity in patients with gastrointestinal stromal tumors with <em>KIT</em> and <em>PDGFRA</em> mutations, according to findings from the phase I NAVIGATOR trial presented at the 2018 CTOS Annual Meeting. To date, patients with GIST who harbor these mutations have typically been resistant to all available therapies.
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Crizotinib Demonstrates Important Clinical Activity in Advanced, Inoperable IMFT
November 17th 2018Half of the patients with inflammatory myofibroblastic tumor (IMFT) demonstrated a response to crizotinib (Xalkori), according to results from the EORTC phase II "CREATE" study 90101 reported at the 2018 CTOS Annual Meeting.
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Avapritinib Could Deliver Precision Medicine to Patients With GIST, Says Heinrich
November 17th 2018The investigational agent avapritinib demonstrated encouraging response rates in patients with advanced gastrointestinal stromal tumors and PDGFRα D842V-driven GIST, according to findings presented during the 2018 Annual Meeting of the Connective Tissue Oncology Society in Rome, Italy.
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Treatment Type and Cognitive Impairment in GIST
November 16th 2018During the 2018 Annual Meeting of the Connective Tissue Oncology Society, Anette Duensing, MD, assistant professor of pathology at University of Pittsburgh, discusses the need for further investigation into how treatment type impacts perceived cognitive function in patients with gastrointestinal stromal tumor.
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Crizotinib Holds Promise for Treating IMFT, Says Schoffski
November 15th 2018Patrick Schöffski, MD, MPH, discussed the key findings from the CREATE trial, the next steps for research into inflammatory myofibroblastic tumor, and the regulatory challenges for approval of drugs for rare cancers.
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Practice-Changing Survival Improvements Seen With Maintenance Chemo in Pediatric Rhabdomyosarcoma
June 4th 2018Practice-changing improvements in disease-free survival and overall survival rates were seen for patients with pediatric rhabdomyosarcoma with the addition of a course of low-dose maintenance chemotherapy administered after standard-of-care intensive chemotherapy.
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Larotrectinib Granted FDA's Priority Review for NTRK+ Cancers
May 29th 2018A new drug application for larotrectinib has been granted a priority review by the FDA for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors with an <em>NTRK</em> gene fusion, according to Bayer and Loxo Oncology, the codevelopers of the pan-TRK inhibitor.
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Larotrectinib Excites in TRK Fusion Cancers for Both Adult and Pediatric Patients
April 27th 2018When findings of larotrectinib, a pan-TRK inhibitor co-developed by Bayer and Loxo Oncology, that generated significant excitement for the treatment of both adult and pediatric patients with TRK fusion cancers, were presented during the 2017 ASCO Annual Meeting, the small molecule was lauded as a future standard of care for patients with advanced solid tumors harboring a TRK fusion.
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Crizotinib Reaches 100% Disease Control Rate in ALK+ Inflammatory Myofibroblastic Tumors
April 16th 2018In a precision medicine success story, crizotinib (Xalkori) demonstrated a 50% objective response rate and a 100% disease control rate in patients with <em>ALK</em>-positive advanced, inoperable inflammatory tumors, in findings from the CREATE study presented at the 2018 AACR Annual Meeting.
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