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FLASCO News

FDA approves brigatinib for ALK-positive metastatic NSCLC

On May 22, 2020, the Food and Drug Administration approved brigatinib (ALUNBRIG®, ARIAD Pharmaceuticals Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. Today, the FDA also approved the Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular, Inc.) as a companion diagnostic...

FDA approves ripretinib for advanced gastrointestinal stromal tumor

On May 15, 2020, the Food and Drug Administration approved ripretinib (QINLOCK™, Deciphera Pharmaceuticals, LLC.), for adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. Efficacy was evaluated in INVICTUS (NCT03353753), an international, multi-center, randomized (2:1), double-blind, placebo-controlled trial in 129 patients with...

FDA grants accelerated approval to rucaparib for BRCA-mutated metastatic castration-resistant prostate cancer

On May 15, 2020, the Food and Drug Administration granted accelerated approval to rucaparib (RUBRACA®, Clovis Oncology, Inc.) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Efficacy was investigated in TRITON2 (NCT02952534), an ongoing, multi-center, single arm clinical trial...

FDA approves nivolumab plus ipilimumab for first-line mNSCLC (PD-L1 tumor expression ≥1%)

On May 15, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO®, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY®, Bristol-Myers Squibb Co.) as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1(≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma...

FDA grants accelerated approval to pomalidomide for Kaposi sarcoma

From the American Society of Clinical Oncology in cooperation with the Food and Drug Administration (FDA) and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. This helps FDA inform oncologists and professionals in oncology-related fields about recent approvals in a timely manner. Included in the...

FCS patients report high satisfaction with care during Covid-19 pandemic

Cancer Patients Report High Satisfaction with Care During COVID-19 Pandemic Florida Cancer Specialists & Research Institute establishes protocols to protect patients with minimal disruption Fort Myers, Fla., May 19, 2020 —— Despite the many challenges of the current health care crisis, patients of  Florida Cancer Specialists & Research Institute (FCS) report high satisfaction with the oncology provider’s response...

FDA approves olaparib for HRR gene-mutated metastatic castration-resistant prostate cancer

On May 19, 2020, the Food and Drug Administration approved olaparib (LYNPARZA®, AstraZeneca Pharmaceuticals, LP) for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC), who have progressed following prior treatment with enzalutamide or abiraterone. Today, the FDA also approved FoundationOne® CDx (Foundation Medicine, Inc.)...

New name for Takeda Oncology patient support program

Takeda Oncology has changed the name of their patient support program from Takeda Oncology 1Point to Takeda Oncology Here2Assist™ effective May 18, 2020. Please note that only the name is changing. Patients and providers will continue to have the same high level of comprehensive, personalized support. Please review the attached information for important details.

FDA approves atezolizumab for first-line treatment of metastatic NSCLC with high PD-L1 expression

On May 18, 2020, the Food and Drug Administration approved atezolizumab (TECENTRIQ®, Genentech Inc.) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of...

FDA approves nivolumab plus ipilimumab for first-line mNSCLC (PD-L1 tumor expression ≥1%)

On May 15, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO®, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY®, Bristol-Myers Squibb Co.) as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1(≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma...

Genentech Response to Patient Access Needs During COVID-19

Hello, At Genentech, we recognize that the COVID-19 national public health emergency is causing personal and financial challenges for many patients and their families. Getting their prescribed Genentech medicines shouldn’t be one of those challenges.  Our highest priority is the health and safety of patients, and we believe it is critical for them to continue...

Webinar: Mantle Cell Lymphoma Education Program

We invite you to learn more about: Current and emerging treatment options for Mantle Cell Lymphoma (MCL), Side-effect management and Ways to effectively communicate with your healthcare team about quality-of-life issues

Dear FLASCO Member, We at FLASCO recognize how vital your role is – especially during these difficult times.  Together with Pfizer, to help support your efforts to effectively engage patients and provide quality care, we are offering a virtual speaker series titled Challenges, Opportunities and Goals of Patient-Provider Communications: Focus on  Compassion Fatigue and Burnout.  You’ll see that...

Eli Lilly and Company

FDA approves selpercatinib for lung and thyroid cancers with RET gene mutations or fusions

On May 8, 2020, the Food and Drug Administration granted accelerated approval to selpercatinib (RETEVMOTM, Eli Lilly and Company) for the following indications: Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC); Adult and pediatric patients ≥12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy;...

astrazeneca

FDA expanded the indication of olaparib to include its combination with bevacizumab

Food and Drug Administration expanded the indication of olaparib (LYNPARZA®, AstraZeneca Pharmaceuticals, LP) to include its combination with bevacizumab for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination...

Florida Precision Oncology have opened their practice to offer Telehealth support

Drs. Mudad, Santos, Blanc and Jahanzeb of Florida Precision Oncology have opened their practice to Telehealth second opinions for your patients to avoid travel and receive expert advice from the comfort of their home while staying under your competent care. Contact 1-833-376-6265 (1-833-fponcol) for additional information.   If your practice is offering services you would...

Announcing the launch of the COVID-19 Emergency Food Assistance Program

Good afternoon Bristol Myers Squibb Foundation Friends, Partners and Colleagues: We are excited to be sharing with you the launch of the COVID-19 Emergency Food Assistance Program, designed to keep immunocompromised patients safe during the COVID-19 Pandemic. This comprehensive program brings together the unique offerings of Team Rubicon, a nonprofit organization that serves communities by mobilizing veterans...

FDA grants accelerated approval to capmatinib for metastatic non-small cell lung cancer

On May 6, 2020, the Food and Drug Administration granted accelerated approval to capmatinib (TABRECTATM, Novartis) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. Today, FDA also approved the FoundationOne CDx assay (Foundation...

Bayer and NeoGenomics Launch the Test4TRKTM Program to Provide Genomic Cancer Testing at No Cost for People Living with Advanced Thyroid and Colorectal Cancers

Bayer today announced the launch of Test4TRKTM program in collaboration with NeoGenomics, Inc. to offer genomic cancer testing for NTRK gene fusions at no cost for patients with RAI-refractory (RAI-R) differentiated thyroid carcinoma (DTC) and metastatic colorectal cancer (mCRC) with high microsatellite instability (MSI-H). NTRK gene fusions, which have been shown to drive tumor growth, are more commonly found in patients with MSI-H mCRC and RAI-R DTC and may play a role in disease management.

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