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Re: FDA approves Exelixis' Cabometyx thyroid cancer treatment - the approval came months earlier than 4Dec2021 PDUFA date“a testament to the outrageously good Hazard Ratio (HR) of 0.22, translating into a 78 percent reduction of disease progression.” Perhaps late to the game? The 11 months cabo vs. 1.9 months placebo HR 0.22 is comparable to lenvatinib 18.3 vs. 3.6 months placebo HR 0.21 (79% reduction of disease progression). Lenvatinib had a stat sig ORR 65% vs 2% compared to cabo 15% vs. 0% which was not considered to be significant. https://www.healio.com/news/hematology-oncology/20190709/new-treatments-new-outcomes-for-refractory-thyroid-cancer Sorafenib (Nexavar; Bayer, Onyx Pharmaceuticals), approved in 2013, and lenvatinib (Lenvima, Eisai), approved in 2015, are two tyrosine kinase inhibitors that have been the mainstay of treatment for iodine-refractory DTC. These TKIs, along with vandetanib (Caprelsa, Sanofi Genzyme) — a kinase inhibitor approved by the FDA for treatment of patients with symptomatic or progressive medullary thyroid cancer who have unresectable locally advanced or metastatic disease — are the only agents that have been evaluated in randomized phase 3 trials vs. placebo for the treatment of refractory thyroid cancer. In the DECISION trial, researchers randomly assigned 417 treatment-naive patients with radioactive iodine-refractory locally advanced or metastatic DTC that had progressed within the past 14 months to sorafenib 400 mg twice daily or placebo. Sorafenib improved median PFS compared with placebo across subgroups (median, 10.8 months vs. 5.8 months; HR = 0.58; 95% CI, 0.45-0.75). The partial response rate was 12%, and 41.8% of participants achieved stable disease for 6 months or longer. In the SELECT trial, researchers randomly assigned 392 patients with radioactive iodine-refractory locally advanced or metastatic DTC that had progressed within the past 13 months to lenvatinib 24 mg per day or placebo. Lenvatinib significantly prolonged median PFS compared with placebo (18.3 months vs. 3.6 months; HR = 0.21; 99% CI, 0.14-0.31). The objective response rate was 65%, with complete responses in 2% of patients.” In VERIFY — a randomized controlled trial comparing vandetanib vs. placebo among 238 patients — researchers observed a nonsignificant improvement in median PFS (10 months vs. 5.7 months). Data from the phase 3 ZETA trial presented at European Society for Medical Oncology Congress showed vandetanib induced tumor shrinkage that persisted throughout multiple treatment lines for patients with advanced unresectable medullary thyroid cancer.” Lenvatinib dominated the market because it gives you a 65% chance of response to PFS but, unfortunately, 75% of patients require a dose reduction,” Krzysztof Misiukiewicz, MD, associate professor of medicine, hematology and medical oncology, and assistant professor of otolaryngology at Icahn School of Medicine at Mount Sinai, told HemOnc Today. “I always counsel my patients that I start high and then de-escalate the treatment if they experience side effects. ... With most of the patients I treat, we can find a dose that is satisfactory for the patient and provides efficacy.” The FDA approved several new therapies for the treatment of thyroid cancer last year. Although these approvals are not specific to radioactive iodine-refractory disease, they may provide another treatment option for a subset of patients with specific genetic alterations. |
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Msg # | Subject | Author | Recs | Date Posted |
28010 | Re: FDA approves Exelixis' Cabometyx thyroid cancer treatment - the approval came months earlier than 4Dec2021 PDUFA date | JBWIN | 9 | 9/17/2021 6:35:18 PM |
28012 | Re: FDA approves Exelixis' Cabometyx thyroid cancer treatment - the approval came months earlier than 4Dec2021 PDUFA date | JoeFlow | 3 | 9/17/2021 8:33:30 PM |
28013 | Re: FDA approves Exelixis' Cabometyx thyroid cancer treatment - the approval came months earlier than 4Dec2021 PDUFA date | SirCharlesMartin | 5 | 9/17/2021 8:44:13 PM |