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FDA Approval Summary: Sonidegib for Locally Advanced Basal Cell Carcinoma.

Author: CaseyDenise, ChenHuanyu, DemkoSuzanne, HeKun, HelmsWhitney, KeeganPatricia, PazdurRichard, PutmanAlexander, ShordStacy, ZhaoHong

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Overview

Sonidegib (ODOMZO) was approved for treating locally advanced basal cell carcinoma (laBCC) based on a trial of 230 patients. The objective response rate (ORR) was 58% in the 200 mg group and 44% in the 800 mg group for patients with laBCC. The most common side effects were muscle spasms, alopecia, dysgeusia, nausea, fatigue, increased serum creatine kinase, decreased weight, and diarrhea.
Paper Details　
Original Abstract of the Article :
On July 24, 2015, the FDA approved sonidegib (ODOMZO; Novartis) for the treatment of patients with locally advanced basal cell carcinoma (laBCC) not amenable to curative surgery or radiotherapy. The approval was based on data from one randomized, double-blind, noncomparative trial of two doses of so...See full text at original site
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引用元：
https://doi.org/10.1158/1078-0432.CCR-16-2051

データ提供：米国国立医学図書館（NLM）

Sonidegib for Locally Advanced Basal Cell Carcinoma: A Camel's Journey Through the Desert of Cancer

Locally advanced basal cell carcinoma (laBCC), a challenging form of skin cancer, often requires aggressive treatment approaches. This study explores the potential of sonidegib, a hedgehog inhibitor, as a treatment option for patients with laBCC not amenable to surgery or radiotherapy.

A New Oasis in the Desert: Sonidegib Shows Promise

Sonidegib demonstrated promising results in treating laBCC, achieving an objective response rate of 44% to 58% in patients receiving either 200 mg or 800 mg daily. The study highlighted the potential of sonidegib as a valuable tool in the fight against laBCC, offering a glimmer of hope in the desert of cancer treatments. It also underscores the need for further research to optimize dosage and treatment strategies, ensuring the best possible outcomes for patients.

Navigating the Side Effects: A Camel's Guide to Treatment

While sonidegib shows promise in treating laBCC, it is important to understand its potential side effects, much like a camel navigating a terrain filled with prickly cacti. The most common adverse events included muscle spasms, alopecia, and dysgeusia. Close monitoring and careful management of these side effects are essential for maximizing patient comfort and treatment success.

Dr. Camel's Conclusion

The battle against cancer is a challenging journey through a vast and unforgiving desert. This study, like a well-placed oasis, offers hope with the introduction of sonidegib, a new weapon in the fight against laBCC. While side effects should be carefully monitored, sonidegib's efficacy suggests a promising future for patients seeking treatment options for this challenging form of cancer. The desert of cancer research is vast, but with persistent exploration and innovative therapies, we can find new oases of hope for those facing this formidable disease.
Date :
  1. Date Completed 2018-02-22
  2. Date Revised 2022-03-11
Further Info :

Pubmed ID

28073840

DOI: Digital Object Identifier

10.1158/1078-0432.CCR-16-2051

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Article Analysis
・Side Effects of sonidegib
SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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