KZA Media Thread, page-1219

FDA Approves Selinexor for Refractory or Relapsed Multiple Myeloma and Relugolix for Advanced Prostate Cancer.As a service to our members, the American Association for Cancer Research will distribute information from the U.S. Food and Drug Administration about newly approved novel therapies for cancer patients. By doing so, we aim to help the FDA inform cancer researchers and oncologists of recent approvals in a timely manner. Included in the email from the FDA will be a link to the product label, which will provide the relevant clinical information on the indication, contraindications, dosing, and safety. In sharing this information, the AACR does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described. On December 18, 2020, the Food and Drug Administration approved selinexor (XPOVIO, Karyopharm Therapeutics Inc.) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.FDA granted selinexor accelerated approval in 2019 in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.Efficacy of selinexor in combination with bortezomib and dexamethasone was evaluated in the BOSTON Trial (KCP-330-023, NCT03110562), a randomized (1:1) open-label, multicenter, active comparator-controlled trial in patients with RRMM who had previously received at least one and at most three prior therapies. Patients received once-weekly selinexor orally in combination with once-weekly bortezomib subcutaneous and low-dose dexamethasone twice-weekly orally (SVd) compared to the standard twice-weekly bortezomib plus low-dose dexamethasone (Vd).The main efficacy outcome measure was progression free survival (PFS) assessed by an independent review committee using International Myeloma Working Group response criteria. The estimated median PFS was 13.9 months (95% CI: 11.7, Not Estimable) for the SVd arm and 9.5 months (95% CI: 7.6, 10.8) for the Vd arm (estimated hazard ratio 0.70; 95% CI: 0.53, 0.93).Common adverse reactions reported in at least 20% of patients include nausea, fatigue, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection decreased weight, cataract and vomiting. Grade 3-4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia hyponatremia and neutropenia.The prescribing information provides warnings and precautions for thrombocytopenia, neutropenia, gastrointestinal toxicity, hyponatremia, serious infection, neurological toxicity, embryo-fetal toxicity and cataract.The recommended selinexor dose is 100 mg orally once weekly on day 1 of each week of a 35-day cycle until disease progression or unacceptable toxicity in combination with: Bortezomib 1.3 mg/m2 administered subcutaneously once weekly on day 1 of each week for 4 weeks followed by 1 week off. Dexamethasone 20 mg taken orally twice weekly on days 1 and 2 of each week. Instruct patients to swallow tablets whole and not to crush or chew tablets


So...."Estimated" PFS of 13.9 months vs. 9.5 months. Yeah, AE's, but at least it's sub-q (a shot). Don't crush or chew! FD approval.

I've said it before, Paxalisib vs. DIPG (in combo with ONC-201) IND and approval will be before that for Pax vs. GBM.

Actually, don't listen to me because I'm an idiot. Think for yourselves.