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March 7, 2020
Tazemetostat Approved for Treatment of Sarcoma: Tazemetostat (Tazverik) is the first EZH2 inhibitor approved by the FDA and is indicated for adults and children older than 16 for the treatment of epithelioid sarcoma. In a phase II, open-label trial of patients with locally-advanced or metastatic epithelioid sarcoma, 62 patients were treated with tazemetostat 800 mg orally twice a day. The disease control rate (defined as complete responses, partial response and stable disease) was 26% (15/62) with a median overall survival of 82.4 weeks (95% CI: 47.4, not estimable) for all 62 pts. Tazemetostat was well tolerated; the most common adverse effects were fatigue and nausea.
August 28, 2019
Erdafitnib Approved for FGFR Mutated Bladder Cancers: Erdafitnib (Balversa®) is the first FGFR inhibitor approved by the FDA and is indicated for adults with FGFR3 or FGFR2 mutations in locally advanced and unresectable or metastatic bladder cancer who have progressed on prior therapy. FGFR mutations are common, occurring in up to 60% of bladder cancers. In an open-label, multicenter, Phase II trial, the median progression free survival was 5.5 months (95% CI, 4.2-6.0). The overall response rate to erdafitnib was 40%. The most common adverse effects were hyperphosphatemia, stomatitis and diarrhea.
May 7, 2019
ASCO Practice Guidelines on Management of Immune-Related Adverse Events in Patients Treated with Immune Checkpoint Inhibitors: In February 2018, the American Society of Clinical Oncology (ASCO) published a new guideline regarding the management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy. Recommendations are outlined by organ-specific toxicities with diagnosis and management criteria presented. Differences in treatment approaches exist, but most patients with Grade 1 toxicities may continue immune checkpoint inhibitor therapy. Corticosteroids may be initiated for Grade 3 toxicities and higher and must be tapered over at least 4 to 6 weeks. In severe and refractory cases, other immunosuppressive therapies may be required to control immune-related adverse events. In most cases, immune checkpoint inhibitor therapy is permanently discontinued with Grade 4 toxicities.
March 4, 2019
Larotrectinib Approved for NTRK Fusion Cancers: Larotrectinib (Vitrakvi®) is the first disease agnostic small molecule inhibitor approved by the FDA and is indicated for adult and pediatric patients with NTRK fusion cancers. While NTRK fusions are rare, occurring in ~ 1% of all cancers, they are common in some rare cancers such as secretory carcinoma of the breast. Overall response rate in NTRK fusion cancers is 75%. The most common adverse effects are elevations in LFTs and anemia, with serious neuropathies in about 1% of patients. Larotrectinib is first line therapy in metastatic disease if no standard therapies are available or after initial disease progression.
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