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The clonoSEQ® Assay is now FDA-cleared and covered by Medicare for detecting and monitoring MRD in bone marrow samples from patients with multiple myeloma or B-cell ALL.

View our Medicare coverage press release here. For more info about clonoSEQ, including test limitations, read the Technical Summary here. ABOUT ADAPTIVE BIOTECHNOLOGIES   As a pioneer and leader in the field of immunosequencing, Adaptive Biotechnologies combines next generation sequencing (NGS) and proprietary bioinformatics to profile T-cell and B-cell receptors to drive groundbreaking research in cancer and other...

FDA Approves Exelixis’ Cabozantinib for Advanced HCC

The FDA has approved cabozantinib (Cabometyx) as a treatment for patients with hepatocellular carcinoma (HCC) who previously received sorafenib (Nexavar), according to the company developing the therapy, Exelixis. The approval was based on findings from the phase III CELESTIAL trial, in which overall survival (OS) was improved by 2.2 months with cabozantinib versus placebo. Median...

Bristol-Myers Squibb’s Sprycel® (dasatinib) Tablets Now Approved in Combination with Chemotherapy in Certain Pediatric Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Press Release See All Press Releases      Sign up for Email Alerts      Press Release RSS Sprycel is the first and only second-generation tyrosine kinase inhibitor for pediatric patients for the treatment of newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia in combination with chemotherapy Approval marks second pediatric leukemia indication for Sprycel 1 CATEGORY:  CORPORATE/FINANCIAL NEWSWEDNESDAY, JANUARY 2, 2019 4:25 PM EST#FDA...

FDA-Approved Indication for KEYTRUDA® (pembrolizumab) for the Treatment of Adult and Pediatric Patients With Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma (MCC)

Merck is pleased to announce that KEYTRUDA has been approved by the FDA for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic MCC. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and...

NEW FDA approval- Stemline Therapeutics

Stemline Therapeutics recently announced that the Food and Drug Administration (FDA) has approved ELZONRISTM (tagraxofusp-erzs; SL-401) for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN): https://ir.stemline.com/news-releases/news-release-details/fda-approves-elzonristm-tagraxofusp-first-treatment-blastic Full prescribing information can be found here:http://elzonris.com/hcp/resources/ELZONRIS_US_Full_Prescribing_Information.pdf ELZONRISTM will not be available for shipment until late January.  We are currently in the process of finalizing a compliment of clinical and patient focused resources. ...

astrazeneca

FDA approves olaparib for first-line maintenance of BRCA-mutated advanced ovarian cancer

On December 19, 2018, the Food and Drug Administration approved olaparib (LYNPARZA, AstraZeneca Pharmaceuticals LP) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Patients with gBRCAm advanced...

FDA approves longer-acting calaspargase pegol-mknl for ALL

On December 20, 2018, the Food and Drug Administration approved calaspargase pegol-mknl (ASPARLAS™, Servier Pharmaceuticals LLC), an asparagine specific enzyme, as a component of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years. This new product provides for a longer interval between doses compared to...

FDA approves tagraxofusp-erzs for blastic plasmacytoid dendritic cell neoplasm

On December 21, 2018, the Food and Drug Administration approved tagraxofusp-erzs(ELZONRIS™, Stemline Therapeutics), a CD123-directed cytotoxin, for blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. Approval was based on a multicenter, multicohort, open-label, single-arm clinical trial (STML-401-0114; NCT 02113982) in patients with untreated or relapsed/refractory BPDCN. Patients...

alexion

FDA approves Alexion’s ravulizumab-cwvz for paroxysmal nocturnal hemoglobinuria

On December 21, 2018, the Food and Drug Administration approved ravulizumab-cwvz (ULTOMIRIS, Alexion Pharmaceuticals, Inc.) for adult patients with paroxysmal nocturnal hemoglobinuria (PNH). Approval was based on two open-label, randomized, active-controlled, non-inferiority phase 3 studies: ALXN1210-PNH-301 (NCT02946463) and ALXN1210-PNH-302 (NCT03056040). Study 301 enrolled 246 patients with PNH who were complement inhibitor naïve and had active...

FDA approves pembrolizumab for Merkel cell carcinoma

On December 19, 2018, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co. Inc.) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). Approval was based on Cancer Immunotherapy Trials Network protocol 9 (CITN-09), also known as KEYNOTE-017 (NCT02267603), a multicenter, non-randomized, open-label trial...

astrazeneca

Reimbursement Update Permanent J code for Imfinzi

IMFINZI is indicated for the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.  The NEW Permanent J-Code is J91731 and goes into effect January 1, 2019.

ASH 2018 News From Genentech

This year at the American Society of Hematology (ASH) Annual Meeting, Genentech presented data for ten medicines in more than 70 abstracts, including 25 oral presentations [press release]. Highlighted data included new data from three Venclexta® (venetoclax) combination studies demonstrating deep responses in chronic lymphocytic leukemia and acute myeloid leukemia, two of the most common types...

Entrinsic Health Solutions and Markey Cancer Center Launch Phase II Study for Neuroendocrine Tumor Patients with Quality of Life-Limiting Diarrhea

NORWOOD, Mass., Dec. 12, 2018 /PRNewswire/ — Entrinsic Health Solutions in partnership with the University of Kentucky (UK) Markey Cancer Center today announced initiation of active accrual and first consented patient in its Phase II study evaluating enterade® – a glucose-free, medical food – in neuroendocrine tumor and carcinoid syndrome patients. Findings from this study may show that enterade can...

Announcing a New First-Line Indication for a Genentech Therapy

Click here to learn more.   TECENTRIQ PI Genentech isexcited to share the news of a new FDA-approved indication. TECENTRIQ®(atezolizumab), in combination with Avastin® (bevacizumab), paclitaxel, andcarboplatin, is now indicated for the first-line treatment of patientswith metastatic non-squamous non-small cell lung cancer (nsqNSCLC) with no EGFRor ALK genomic tumor aberrations. Please see the attached TECENTRIQ 1L NSCLC...

Permanent J-codes for Genentech Hematology Products

 The Centers for Medicare & Medicaid Services (CMS) has made a change to the RITUXAN® (rituximab) J-code and has assigned a permanent J-code for RITUXAN HYCELA® (rituximab/hyaluronidase human subcutaneous injection). Effective January 1, 2019 J-code J9312 will replace J9310 for RITUXAN and the billable units will change from 100 mg to 10 mg. Additionally, the...

C-code for ONPATTRO™ (patisiran) lipid complex injection

We are sending this communication on behalf of Alnylam Pharmaceuticals, Inc., to announce the assignment of a product‐specific temporary C-code for ONPATTRO™ (patisiran) lipid complex injection, for intravenous use. The Centers for Medicare & Medicaid Services (CMS) released the 2019 Alpha-Numeric HCPCS File, which included the designation of C9036, Injection, patisiran, 0.1 mg for ONPATTRO with the...

New Launch of Product Xospata

Astellas is pleased to announce the product approval of XOSPATA (gilteritinib). For details on the indication for XOSPATA, please reference the attached PDF

New indication for VENCLEXTA(R) (venetoclax tablets)

On November 21, 2018, VENCLEXTA® (venetoclax tablets) was approved by the US Food and Drug Administration (FDA) in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy....

Florida Cancer Specialists & Research Institute, LLC Supports the 2018 FLASCO Fall Session in Orlando

Fort Myers, FL – November 29th, 2018… The Florida Society of Clinical Oncology (FLASCO) hosted the 2018 FLASCO Fall Session, November 8th-10th, in Orlando, Florida at the Orlando World Center Marriott with approximately 450 attendees. More than 30 Florida Cancer Specialists (FCS) physicians and staff were in attendance, in addition to numerous FCS FLASCO Board Members and Liaisons....

FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma

The U.S. Food and Drug Administration approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy. Truxima is the first biosimiliar to be approved in the U.S. for the treatment of...

FDA approves Bayer’s larotrectinib for solid tumors with NTRK gene fusions

On November 26, 2018, the Food and Drug Administration granted accelerated approval to larotrectinib (VITRAKVI, Loxo Oncology Inc. and Bayer) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to...

The antidiarrheal efficacy of a proprietary amino acid mixture in neuroendocrine tumor (NET) patients.

Clinical data for neuroendocrine tumor patients. Entrinsic recently presented data at ASCO’s Palliative and Supportive Care in Oncology Symposium. Updated clinical results showed that 80% of NET patients reported reduction in diarrhea frequency using enterade. In addition,51% of patients reported more than 50% reduction in frequency. Diarrhea is the most common and debilitating symptom among NET cancer patients. Please...

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