FLASCO News

FDA

FDA Approves VEKLURY (Remdesivir)

On October 22, 2020, the U.S. Food and Drug Administration (FDA) approved VEKLURY (remdesivir) for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization. VEKLURY should only be administered intravenously (IV) in a hospital or in a healthcare...

Genentech

FDA Grants Full Approval For Venclexta In AML

On Friday, the FDA granted full approval for Venclexta (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Venclexta was previously granted provisional approval in this...

Bristol Myers Squibb

FDA Approves Opdivo + Yervoy for Previously Untreated Unresectable Malignant Pleural Mesothelioma

Opdivo + Yervoy is the first new systemic therapy in over 15 years to be approved by the FDA in this setting1,2 Approval is based on CheckMate -743 in which Opdivo + Yervoy demonstrated superior overall survival vs. standard of care chemotherapy1 Approval marks third indication for Opdivo + Yervoy-based treatments in thoracic cancers and seventh indication overall PRINCETON,...

Blueprint

FDA Approves GAVRETO (Pralsetinib) For Adult Patients with Metastatic Rearranged During Transfection Fusion-Positive Non-Small Cell Lung Cancer

On September 4, 2020, the U.S. Food and Drug Administration (FDA) approved GAVRETO (pralsetinib) for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. Select patients for treatment with GAVRETO based on the presence of a RET gene fusion. Information on...

Celgene

FDA approves Onureg (azacitidine tablets) for acute myeloid leukemia

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...

Celgene

FDA approves Onureg (azacitidine tablets) for acute myeloid leukemia

On September 1, 2020, the Food and Drug Administration approved azacitidine tablets (ONUREG®, Celgene Corporation) for continued treatment of patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy. More information.

Bristol Myers Squibb

FDA approves Onureg (azacitidine tablets) for acute myeloid leukemia

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...

Janssen | Johnson & Johnson

FDA approves carfilzomib and daratumumab with dexamethasone for multiple myeloma

On August 20, 2020, the Food and Drug Administration approved carfilzomib (KYPROLIS, Onyx Pharmaceuticals, Inc.) and daratumumab (DARZALEX, Janssen Biotech, Inc.) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. The efficacy of carfilzomib and daratumumab with dexamethasone was evaluated in two...

FDA

CAR T-Cell Therapy Approved by FDA for Mantle Cell Lymphoma

A CAR T-cell therapy called brexucabtagene autoleucel (Tecartus) has been approved by the Food and Drug Administration (FDA) for some patients with mantle cell lymphoma. This is the third CAR-T cell therapy approved by FDA for patients with cancer. Read more >

Guardant Health

FDA Approves First Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test

Today, the U.S. Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology to identify patients with specific types of mutations of the epidermal growth factor receptor (EGFR) gene in a deadly form of metastatic non-small cell lung cancer (NSCLC). This is the first approval to combine...

GlaxoSmithKline

FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myeloma

On August 5, 2020, the Food and Drug Administration approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline) for adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. Belantamab mafodotin-blmf was evaluated in DREAMM-2 (NCT 03525678), an open-label, multicenter trial....

FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma

On July 31, 2020, the Food and Drug Administration granted accelerated approval to tafasitamab-cxix (MONJUVI, MorphoSys US Inc.), a CD19-directed cytolytic antibody, indicated in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for...

Genentech

FDA approves atezolizumab for BRAF V600 unresectable or metastatic melanoma

On July 30, 2020, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. Efficacy in combination with cobimetinib and vemurafenib was evaluated in a double-blind, randomized (1:1), placebo-controlled, multicenter trial (IMspire150, NCT02908672) in 514 patients. After a 28-day...

Kite

FDA Approves First Cell-Based Gene Therapy For Adult Patients with Relapsed or Refractory MCL

Today, the U.S. Food and Drug Administration approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment of adult patients diagnosed with mantle cell lymphoma (MCL) who have not responded to or who have relapsed following other kinds of treatment. Tecartus, a chimeric antigen receptor (CAR) T cell therapy, is the first cell-based gene therapy...

Kite

FDA Approves First Cell-Based Gene Therapy For Adult Patients with Relapsed or Refractory MCL

On July 24, 2020, the U.S. Food and Drug Administration approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment of adult patients diagnosed with mantle cell lymphoma (MCL) who have not responded to or who have relapsed following other kinds of treatment. Tecartus, a chimeric antigen receptor (CAR) T cell therapy, is the first...

Genentech

Announcing a New Genentech Therapy

Genentech is excited to share the news of the Food and Drug Administration (FDA) approval of PHESGO™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf) injection, for subcutaneous use. PHESGO is a fixed-dose combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase. Indications Early Breast Cancer PHESGO™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf) is indicated for use in combination with...

Taiho Oncology

FDA Approves New Therapy for Myelodysplastic Syndromes (MDS) That Can Be Taken at Home – Drug Information Update

Today, the U.S. Food and Drug Administration approved Inqovi (decitabine and cedazuridine) tablets for treatment of adult patients with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML). This represents an important advance in treatment options for patients with MDS, a type of blood cancer, who previously needed to visit a health care facility to receive...

Dr. Cassell

In Memory of Dr. Robert Cassell

With heavy hearts, FLASCO is saddened to announce the passing of longtime FLASCO member, Robert ‘Bob’ Cassell, MD, PhD.  Dr. Cassell passed away Tuesday, June 30th in Winter Haven, Florida, after battling COVID.  Dr. Cassell was a longtime member of FLASCO, serving on the Board of Directors for many years, and as FLASCO President from...

EMD Serono

FDA approved avelumab 6/30/2020

Food and Drug Administration approved avelumab (BAVENCIO, EMD Serono, Inc.) for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. More Information. June 30, 2020 https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-avelumab-urothelial-carcinoma-maintenance-treatment Hematology/Oncology (Cancer) Approvals & Safety Notifications https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications

Genentech

FDA approves combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf for HER2-positive breast cancer

On June 29, 2020, the Food and Drug Administration approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase–zzxf (PHESGO®, Genentech, Inc.) for subcutaneous injection for the following indications: Use in combination with chemotherapy as: • neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm...

Merck

FDA Approves First-Line Immunotherapy for Patients with MSI-H/dMMR Metastatic Colorectal Cancer – Drug Information Update

The U.S. Food and Drug Administration approved Keytruda (pembrolizumab) for intravenous injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. This marks the first immunotherapy approved for this patient population as a first-line treatment and which is administered to patients without also giving...

Genentech

FDA approves combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf for HER2-positive breast cancer

On June 29, 2020, the Food and Drug Administration approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase–zzxf (PHESGO®, Genentech, Inc.) for subcutaneous injection for the following indications: Use in combination with chemotherapy as: • neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm...

Merck

FDA approved approved pembrolizumab colorectal cancer

Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co.) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. More Information. June 29, 2020 https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-pembrolizumab-first-line-treatment-msi-hdmmr-colorectal-cancer  Hematology/Oncology (Cancer) Approvals & Safety Notifications https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications

Genentech

FDA Grants Approval to New Fixed-Dose Combination of Perjeta and Herceptin

Genentech announced the FDA granted approval to Phesgo, a new fixed-dose combination of Perjeta and Herceptin available in a single vial. It can be administered under the skin (subcutaneous injection) in just minutes, significantly reducing the amount of time a patient spends receiving treatment when compared to hours with IV administration. The Genentech press release...

CareASSIST Patient Support by Sanofi Genzyme

At the CareASSIST Program by Sanofi Genzyme, our mission is to deliver support services to eligible patients through reliable reimbursement and financial assistance programs. Our dedicated team of CareASSIST Patient Access Specialists strives to ensure that these patients are able to access support through our program. Access and Reimbursement Assistance navigating the insurance process, including...

FDA

FDA approves pembrolizumab for cutaneous squamous cell carcinoma

On June 24, 2020, the Food and Drug Administration approved pembrolizumab (KEYTRUDA®, Merck & Co., Inc.) for patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. Efficacy was investigated in KEYNOTE-629 (NCT03284424), a multicenter, multi-cohort, non-randomized, open-label trial. The trial excluded patients who had previously received...

FDA Approval of XPO1 Inhibitor Compound

Karyopharm Therapeutics Inc. is proud to announce the FDA approval of their lead XPO1 inhibitor compound to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). To learn more about this recent approval, please see the full press release here. (For XPOVIO®(selinexor) full Prescribing Information please visit: XPOVIO Full Prescribing Information.)

Epizyme

FDA granted accelerated approval to tazemetostat for follicular lymphoma

On June 18, 2020, the Food and Drug Administration granted accelerated approval to tazemetostat (TAZVERIK™, Epizyme, Inc.), an EZH2 inhibitor, for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies,...

A product-specific J-code for an mUC treatment is now available

  We are pleased to announce the assignment of a product-specific, permanent J-code for PADCEV. The Centers for Medicare & Medicaid Services (CMS) released the July 2020 Quarterly Healthcare Common Procedural Coding System (HCPCS) File, which includes the designation of J9177 for PADCEV with the effective date of July 1, 2020.1 * Note that the product’s NDC code...

FDA

FDA approves gemtuzumab ozogamicin for CD33-positive AML in pediatric patients

On June 16, 2020, the Food and Drug Administration extended the indication of gemtuzumab ozogamicin (MYLOTARGTM, Wyeth Pharmaceuticals LLC) for newly-diagnosed CD33-positive acute myeloid leukemia (AML) to include pediatric patients 1 month and older. Efficacy and safety in the pediatric population were supported by data from AAML0531 (NCT00372593), a multicenter randomized study of 1,063 patients...

FDA

FDA approves pembrolizumab for adults and children with TMB-H solid tumors

Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co., Inc.) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment...

Sanofi Genzyme

Testing for Gaucher Disease

Gaucher disease is a lifelong, progressive disease. Test to know. It's a simple blood test. Learn more!

Janssen | Johnson & Johnson

COVID-19 Pandemic, New Health Policies and Resources

As our healthcare industry rapidly evolves to address the COVID-19 pandemic, new health policies and resources especially in the areas of patient affordability, care delivery and provider reimbursement continue to be released. That is why we have engaged Avalere, the health policy research firm, to develop and update a repository cataloging significant health policy changes....

ENHERTU® (fam-trastuzumab deruxtecan-nxki)

Effective July 1, 2020, ENHERTU® (fam-trastuzumab deruxtecan-nxki) will have a permanent j-code: J9358. ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2–based regimens in the metastatic setting.1 This indication is approved under accelerated...

Genentech

Genentech is excited to share the news of the new FDA approved indication TECENTRIQ®

Genentech is excited to share the news of the new FDA approved indication. TECENTRIQ® (atezolizumab), in combination with bevacizumab, is indicated for the first-line (1L) treatment of unresectable or metastatic hepatocellular carcinoma (HCC) treatment. Please see attached for additional information, as well as the TECENTRIQ and the Avastin full Prescribing Information, and Important Safety Information for...

FDA

FDA grants accelerated approval to lurbinectedin for metastatic small cell lung cancer

On June 15, 2020, the Food and Drug Administration granted accelerated approval to lurbinectedin (ZEPZELCA, Pharma Mar S.A.) for adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Efficacy was demonstrated in the PM1183-B-005-14 trial (Study B-005; NCT02454972), a multicenter open-label, multi-cohort study enrolling 105 patients with...

FDA approves ramucirumab plus erlotinib for first-line metastatic NSCLC

On May 29, 2020, the Food and Drug Administration approved ramucirumab (CYRAMZA®, Eli Lilly and Company) in combination with erlotinib for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. Efficacy was evaluated in RELAY (NCT02411448), a multinational, randomized, double-blind, placebo-controlled,...

Genentech

FDA approves atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma

On May 29, 2020, the Food and Drug Administration approved atezolizumab in combination with bevacizumab (TECENTRIQ® and AVASTIN®, Genentech Inc.) for patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy. Efficacy was investigated in IMbrave150 (NCT03434379), a multicenter, international, open-label, randomized trial in patients with locally advanced unresectable or metastatic hepatocellular...

GlaxoSmithKline

Complimentary Webinar Series on Multiple Myeloma – GSK

You are invited to a 1 hour webinar, Current and Emerging Trends in Multiple Myeloma, presented by Dr. David Vesole, Myeloma Division and Director, Myeloma Research at the John Theurer Cancer Center at Hackensack. Several different dates and time to choose from in June.

ASCO Virtual Direct™ Highlights Jacksonville | Total Health Conferencing

Due to COVID-19, the ASCO Direct™ Highlights meeting will be virtual. The 2020 ASCO Direct™ Highlights meeting will offer the same benefit that you have come to depend on. The abstracts chosen for presentation and discussion reflect the foremost research and strategies in oncology that directly impact patient care. Expert faculty will place abstract findings into clinical context and discuss how the results may change the current standard of care. Our conferencing platform allows for presentation, discussion, analysis, and attendee participation.

Incyte Corporation Supports FLASCO as a FLASCO Diamond Corporate Member for 2020

The FLASCO leadership is pleased to acknowledge Incyte Corporation as a FLASCO Diamond Corporate Member for 2020.  Please welcome and THANK them for their support, when they call or e-mail you. Incyte is grounded in the rigorous pursuit of scientific excellence and driven to advance medical research to discover, develop and deliver novel medicines that...

Safely reopening amid COVID-19: Vendor/Rep Protocol Updates

RxVantage is offering an on-demand webinar on safely reopening amid COVID-19. Here is the link to the new on-demand webinar. This webinar covers policy recommendations for dealing with your rep/vendor community as well as recommendations for updating protocols to fit social distancing guidelines.

2020 Conquer Cancer – FLASCO Young Investigator Award Recipient

FLASCO is proud to announce the recipient of the 2020 Conquer Cancer -FLASCO Young Investigator Award Zaid H. Abdel Rahman, MD Mayo Clinic, Florida for his work “Evaluating the Impact of Philadelphia‐like Genetic Signature on Transplant Outcomes in Adults with B‐Lymphoblastic Leukemia/Lymphoma and Identification of Novel Fusion Partners”   Dr. Zaid Abdel Rahman is an...

Florida Cancer Specialists Participation at ASCO® Demonstrates Progress Made Through Clinical Research

Virtual gathering delivers the latest cancer science to the global community Fort Myers, Fla., May 27, 2020 ——Florida Cancer Specialists & Research Institute (FCS) physicians are the co-authors of 20 research studies that will be presented at the American Society of Clinical Oncology (ASCO®) ASCO20 Virtual Scientific Program being held May 29 – 31, 2020. As the largest gathering...

FDA approves nivolumab plus ipilimumab and chemotherapy for first-line treatment of metastatic NSCLC

On May 26, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY, Bristol-Myers Squibb Co.) and 2 cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase...

FDA

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...

AstraZeneca

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.)...

Takeda

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.

Genentech

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...

Foundation Medicine

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

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.

Florida Cancer Specialists & Research Institute Provides Hypofractionation Radiation Therapy – Advanced Treatment Option Offers Faster, More Efficient Radiation Therapy for Several Types of Cancers

Fort Myers, Fla., May 6, 2020  — Florida Cancer Specialists & Research Institute (FCS) offers an advanced radiation therapy option for several types of cancers, which can lead to faster and shorter rounds of radiation therapy for patients. Hypofractionated radiation is a treatment technique where the total dose of radiation is delivered in fewer treatment sessions and results...

Janssen | Johnson & Johnson

FDA approves daratumumab and hyaluronidase-fihj for multiple myeloma

On May 1, 2020, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (DARZALEX FASPROTM, Janssen Biotech, Inc.) for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. This new product allows for subcutaneous dosing of daratumumab. Daratumumab and hyaluronidase-fihj is approved for the following indications that intravenous daratumumab had previously received: in combination with...

Janssen | Johnson & Johnson

U.S. Food and Drug Administration Approves DARZALEX FASPROTM (daratumumab and hyaluronidase-fihj), a New Subcutaneous Formulation of Daratumumab in the Treatment of Patients with Multiple Myeloma

Janssen, a Johnson and Johnson pharmaceutical company, is happy to share some exciting news – The FDA just approved DARZALEX FASPRO, a new subcutaneous formulation approved in four regimens across five indications, including newly diagnosed, transplant-ineligible and relapsed or refractory multiple myeloma. As you may know, today’s news is based on results from the COLUMBA...

RxVantage Virtual Meetings news update

In response to COVID-19, RxVantage adds Virtual Meetings to connect healthcare providers to life science experts   RxVantage, the digital education platform that makes it easy for practices to engage with life science companies, today announced the launch of RxVantage Virtual Meetings, a hassle-free digital solution designed to help providers reconnect with life science experts...

Guardant360

Updates regarding patient care during the COVID-19 Pandemic

The NCCN recently published the “Short-Term Recommendations for Non-Small Cell Lung Cancer Management During the COVID-19 Pandemic” and a recent piece was published in JNCCN.  These updates recommend the use of circulating tumor DNA (ctDNA) testing, like Guardant360, for patients progressing on oral therapy rather than having a patient in the hospital for a tissue biopsy. ...

Florida Cancer Specialists & Research Institute Welcomes Dr. Martin F. Dietrich

Medical Oncologist/Hematologist joins FCS in Central Florida Fort Myers, Fla., May 4, 2020 — Florida Cancer Specialists & Research Institute (FCS)  is pleased to welcome Medical Oncologist Martin F. Dietrich, MD, PhD. He is serving patients at the FCS Lake Mary Cancer Center at 805 Currency Circle, Lake Mary, FL and at 2572 W SR 426, Suite 3080,...

GlaxoSmithKline

FDA approves niraparib for first-line maintenance of advanced ovarian cancer

On April 29, 2020, the Food and Drug Administration approved niraparib (ZEJULA, GlaxoSmithKline) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy. Efficacy was investigated in PRIMA (NCT02655016), a double-blind, placebo-controlled trial that randomized 733...

Merck

FDA approves new dosing regimen for pembrolizumab

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...

Janssen | Johnson & Johnson

COVID-19 Telehealth Policy Updates

In response to the COVID-19 pandemic, our healthcare system has had multiple policy changes, offering some flexibility to meet the needs of new patients and for those needing continuity in care.  One of these changes includes access and coverage of telehealth during the current public health emergency. The attached resource from the Center for Connected Health Policy https://www.cchpca.org may...

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