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.
May 3, 2018
American Society of Clinical Oncology (ASCO) Statement on Biosimilars in Oncology: ASCO published a statement providing guidance on biosimilar use in the cancer setting, including: naming, labeling, and other regulatory issues; safety and efficacy; interchangeability, switching, and substitution; value; and prescriber and patient education. To date, the US Food and Drug Administration has approved one biosimilar for supportive cancer care (filgrastim-sndz) and two biosimilars for treatment of cancer (bevacizumab-awwb, trastuzumab-dkst). The statement also affirms ASCO's commitment to providing education to healthcare providers and patients that increases understanding and acceptance of biosimilars, which can improve access to "high-quality, high-value" patient care.
Carcinogenesis is a multistep process that includes initiation, promotion, conversion, and progression.
Cancer cells demonstrate unique traits that distinguish them from normal cells. Cancer cells can stimulate their own growth, resist inhibitory ...