Publications by authors named "L Fashoyin-Aje"
On December 16, 2022, the FDA approved the adenoviral vector-based gene therapy nadofaragene firadenovec-vncg (brand name Adstiladrin) for the treatment of adult patients with high-risk bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). The product represents the first approved adenoviral vector-based gene therapy and the first approved gene therapy for bladder cancer. Determination of efficacy was based on results from Study rAd-IFN-CS-003 (Study CS-003), a single-arm trial in 98 evaluable patients with BCG-unresponsive NMIBC with CIS who received intravesical instillations of the gene therapy product (75 mL of nadofaragene firadenovec at 3 × 1011 viral particles per mL) once every 3 months.
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- On September 2, 2022, the FDA approved durvalumab, and on October 31, 2023, pembrolizumab, both in combination with cisplatin and gemcitabine, for treating unresectable or metastatic biliary tract cancers (BTC).
- The approvals were based on two clinical trials (TOPAZ-1 for durvalumab and KEYNOTE-966 for pembrolizumab), which showed significant improvements in overall survival when these drugs were added to standard chemotherapy compared to placebo.
- Both treatments had safety profiles consistent with existing knowledge and did not show new adverse event signals, providing more options for patients with advanced BTC.
Article Synopsis
- On November 8, 2023, the FDA approved fruquintinib, a drug targeting VEGFR receptors, for treating patients with metastatic colorectal cancer (mCRC) who have undergone specific prior therapies.
- The approval was based on the results from the FRESCO-2 trial, which showed that patients taking fruquintinib had a statistically significant improvement in overall survival compared to those on a placebo.
- Fruquintinib demonstrated a median overall survival of 7.4 months versus 4.8 months for placebo, with side effects consistent with the known safety profile of VEGFR inhibitors.
Importance: Less than 5% of patients with cancer enroll in a clinical trial, partly due to financial and logistic burdens, especially among underserved populations. The COVID-19 pandemic marked a substantial shift in the adoption of decentralized trial operations by pharmaceutical companies.
Objective: To assess the current global state of adoption of decentralized trial technologies, understand factors that may be driving or preventing adoption, and highlight aspirations and direction for industry to enable more patient-centric trials.
Purpose: Little data exist regarding approaches to support oncology professionals who deliver cancer care for underserved populations. In response, ASCO developed the Serving the Underserved Task Force to learn from and support oncology professionals serving underserved populations.
Methods: The Task Force developed a 28-question survey to assess oncology professionals' experiences and strategies to support their work caring for underserved populations.