FLASCO
- Genentech: Diversity & Inclusion May 11, 2023We firmly believe that embracing diversity and inclusion (D&I) drives innovation, improves scientific and clinical outcomes, and contributes to equitable healthcare access for all. Here at Genentech, that means fostering belonging within our own walls, advancing inclusive research and health equity in our industry at-large, and transforming society through partnerships across healthcare, education and within […]
- CancerCoachLive Offers Webinars On Health Equity April 10, 2023CancerCoachLive partners with leading clinical specialists and advocacy organizations to bring free online education to cancer patients and caregivers. CancerCoachLive’s programs are broadcast live through our virtual learning channel, including a panel of experts, interactive Q&A, polling and slides for an immersive learning experience. All of their programmings are available on demand following the live...
- FDA expands early breast cancer indication for abemaciclib with endocrine therapy March 6, 2023On March 3, 2023, the Food and Drug Administration (FDA) approved abemaciclib (Verzenio, Eli Lilly and Company) with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. Patients defined as...
- FDA approves sacituzumab govitecan-hziy for HR-positive breast cancer February 6, 2023On February 3, 2023, the Food and Drug Administration (FDA) approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic...
- Toward Achieving Equity in Cancer Clinical Trials February 1, 2023“Racial and ethnic minorities who are traditionally underrepresented in clinical trials have also had worse clinical outcomes over time. Black patients, for example, have a clinical trial enrollment rate of 4%-6% despite representing 15% of the population and have the highest overall cancer death rate. It has been established that numerous barriers to clinical trial participation exist at...
- Pharmacy Benefit Managers (PBM) Reform January 6, 2023
- FDA grants accelerated approval to mosunetuzumab-axgb for relapsed or refractory follicular lymphoma December 23, 2022On December 22, 2022, the Food and Drug Administration (FDA) granted accelerated approval to mosunetuzumab-axgb (Lunsumio, Genentech, Inc.), a bispecific CD20-directed CD3 T-cell engager for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Mosunetuzumab-axgb was evaluated in GO29781 (NCT02500407), an open-label, multicenter, multi-cohort study. The efficacy...
- FDA approves first adenoviral vector-based gene therapy for high-risk Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer December 19, 2022On December 16, 2022, the Food and Drug Administration approved nadofaragene firadenovec-vncg (Adstiladrin, Ferring Pharmaceuticals) for adult patients with high-risk Bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Efficacy was evaluated in Study CS-003 (NCT02773849), a multicenter, single-arm trial enrolling 157 patients with high-risk...
- FDA approves updated drug labeling including new indications and dosing regimens for capecitabine tablets under Project Renewal December 15, 2022On December 14, 2022, the Food and Drug Administration approved updated labeling for capecitabine tablets (Xeloda, Genentech, Inc.) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date. This is the first drug to...
- FDA grants accelerated approval to adagrasib for KRAS G12C-mutated NSCLC December 13, 2022On December 12, 2022, the Food and Drug Administration (FDA) granted accelerated approval to adagrasib (Krazati, Mirati Therapeutics, Inc.), a RAS GTPase family inhibitor, for adult patients with KRAS G12C¬-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. FDA...