Drugs

FDA grants regular approval to nivolumab for adjuvant treatment of melanoma

• FLASCO
• December 21, 2017
• Drugs
• No Comments

On December 20, 2017, the Food and Drug Administration granted regular approval to the anti-PD1 monoclonal antibody, nivolumab (OPDIVO, Bristol-Myers Squibb Company) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection. Nivolumab was previously approved for the treatment of patients…

FDA grants regular approval to pertuzumab for adjuvant treatment of HER2-positive breast cancer

• FLASCO
• December 21, 2017
• Drugs
• No Comments

On December 20, 2017, the Food and Drug Administration granted regular approval to pertuzumab (PERJETA, Genentech, Inc.) for use in combination with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. Approval was based on data from APHINITY (NCT01358877), a multicenter, randomized, double-blind, placebo-controlled trial in…

FDA grants accelerated approval to bosutinib for treatment of newly-diagnosed PH+ CML

• FLASCO
• December 20, 2017
• Drugs
• No Comments

On December 19, 2017, the Food and Drug Administration granted accelerated approval to bosutinib (BOSULIF, Pfizer Inc.) for treatment of patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML). Approval was based on data from an open-label, randomized, multicenter trial (BFORE, NCT02130557) in 487 patients with Ph+ newly-diagnosed CP CML…

FDA approves Pfizer Biosimilar’s Ixifi (infliximab-qbtx)

• FLASCO
• December 14, 2017
• Drugs
• No Comments

FDA has approved Pfizer Biosimilar’s Ixifi (infliximab-qbtx) for multiple indications.  IXIFI or PF-06438179, infliximab-qbtx is a chimeric human-murine monoclonal antibody or mAb against tumor necrosis factor, as a biosimilar to Remicade or infliximab for all eligible indications of the reference product.This is the third FDA-approved biosimilar to U.S.-licensed Remicade.  For more information, see the approval…

Genentech Presented Data for Ten Medicines

• Amanda Bridges
• December 13, 2017
• Drugs
• No Comments

This year at the American Society of Hematology (ASH) Annual Meeting, Genentech presented data for ten medicines in more than 75 abstracts [press release] including results for: VenclextaTM (venetoclax): Phase III data showing the chemotherapy-free, fixed-duration combination of Venclexta plus with Rituxan reduced the risk of disease worsening or death (progression-free survival; PFS, as assessed by investigator)…

The Centers for Medicare and Medicaid Services (CMS) has granted BAVENCIO® (avelumab)

• Amanda Bridges
• December 11, 2017
• Drugs
• No Comments

Effective for dates of service on or after January 1, 2018, the Centers for Medicare and Medicaid Services (CMS) has granted BAVENCIO® (avelumab) Injection the following permanent Healthcare Common Procedure Coding System (HCPCS) J-Code[1]: J9023 – injection, avelumab, 10mg Full Prescribing Information for BAVENCIO: https://www.bavencio.com/en_US/document/Prescribing-Information.pdf

The FDA has granted full approval for Avastin® (bevacizumab)

• Amanda Bridges
• December 7, 2017
• Drugs
• No Comments

The FDA has granted full approval for Avastin® (bevacizumab) for the treatment of adults with glioblastoma that progressed following prior therapy (referred to as recurrent disease). Avastin was previously granted provisional approval in this setting under the FDA’s accelerated approval program. The Genentech press release, which includes Important Safety Information is available at this link.

FDA approves first biosimilar for the treatment of certain breast and stomach cancers

• FLASCO
• December 1, 2017
• Drugs
• No Comments

The U.S. Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or…

The Centers for Medicare & Medicaid Services (CMS) has assigned a permanent J-code for TECENTRIQ® (atezolizumab)

• Amanda Bridges
• December 1, 2017
• Drugs
• No Comments

Genentech BioOncology is pleased to inform you that the Centers for Medicare & Medicaid Services (CMS) has assigned a permanent J-code for TECENTRIQ® (atezolizumab). The permanent J-code for TECENTRIQ is J9022 (injection, atezolizumab, 10 mg). The J-code goes into effect on January 1, 2018.  Please check with your payers to verify codes and special billing requirements. Also, please…

VARUBI® (rolapitant) injectable emulsion is available through Specialty Distributors

• Amanda Bridges
• November 28, 2017
• Drugs
• No Comments

TESARO is pleased to inform you that VARUBI® (rolapitant) injectable emulsion is available through Specialty Distributors as of Tuesday, 11/28.   Specialty Distributors will begin taking orders on Wednesday, 11/29 for delivery on Thursday, 11/30.   Please visit https://www.VarubiRx.com/en for information on VARUBI, including a description of efficacy, safety and dosing and administration.  TESARO is excited to…

FDA Approves New Two-Drug Regimen for Certain Patients with HIV

• FLASCO
• November 22, 2017
• Drugs
• No Comments

The U.S. Food and Drug Administration today approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment. Juluca is a fixed-dose tablet containing two previously approved drugs (dolutegravir and rilpivirine) to treat…

FDA approves emicizumab-kxwh for prevention and reduction of bleeding in patients with hemophilia A with factor VIII inhibitors

• Amanda Bridges
• November 17, 2017
• Drugs
• No Comments

FDA approved emicizumab-kxwh (HEMLIBRA, Genentech, Inc.) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors. More Information.  November 16, 2017​ Other Hematology/Oncology (Cancer) Approvals & Safety Notifications

FDA expands approval of Sutent to reduce the risk of kidney cancer returning

• FLASCO
• November 17, 2017
• Drugs
• No Comments

The U.S. Food and Drug Administration today approved Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of kidney cancer (renal cell carcinoma) returning after a kidney has been removed (nephrectomy). Adjuvant treatment is a form of therapy that is taken after an initial surgical removal to lower…

FDA Approves PREVYMIS (Letermovir) for Prophylaxis of Cytomegalovirus (CMV) Infection and Disease in Adult CMV-seropositive Recipients [R+] of an Allogeneic Hematopoietic Stem Cell Transplant (HSCT)

• FLASCO
• November 17, 2017
• Drugs
• No Comments

On November 8, 2017, the U.S. Food and Drug Administration (FDA) approved PREVYMIS (letermovir) for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). The approved recommended dosage of PREVYMIS is 480 mg administered once daily orally or as an intravenous (IV) infusion over…

FDA Approves Genentech’s Gazyva for Previously Untreated Advanced Follicular Lymphoma

• FLASCO
• November 17, 2017
• Drugs
• No Comments

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved Gazyva®(obinutuzumab) in combination with chemotherapy, followed by Gazyva alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III or IV). The approval is based on…

DKP Critical Insights Report

• Amanda Bridges
• November 16, 2017
• Drugs
• No Comments

Cancer Drug Access: Clinical Drivers and Influencers The oncology environment changes almost daily, and the integration of clinical perspectives are central to many of the value-based initiatives. Whether understanding the trends in pathway decisions and other unique approaches to managing oncology drugs, or the influence of clinical compendia, these clinical drivers are important. DK Pierce…

How to Diagnose & Test for PNH – Dr. Eloy Roman

• Amanda Bridges
• November 16, 2017
• Drugs
• No Comments

Click here to listen to a 10-minute podcast about PNH from Dr. Roman, a practicing hematologist-oncologist in the Miami area. Learn more about this disease, how to diagnose it, and a case example of how it presented in one of Dr. Roman’s patients with PNH. *These educational programs are offered through the generous support of…

Roche receives FDA clearance for the VENTANA MMR IHC Panel for patients diagnosed with colorectal cancer

• FLASCO
• November 15, 2017
• Drugs
• No Comments

The VENTANA MMR IHC Panel1 helps differentiate between sporadic colorectal cancer and probable Lynch syndrome, a hereditary form of colorectal cancer The National Comprehensive Cancer Network recommends universal screening of all newly diagnosed colorectal cancers for Lynch syndrome Identification of probable Lynch syndrome allows clinicians to recommend additional testing and genetic counseling to patients and at-risk…

Faslodex receives US FDA approval for the treatment of advanced breast cancer in combination with abemaciclib

• FLASCO
• November 15, 2017
• Drugs
• No Comments

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved a new indication for Faslodex(fulvestrant), expanding the indication to include use with abemaciclib, a CDK4/6 inhibitor, for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) in women with disease progression after…

United Healthcare recently made changes that may affect coverage or reimbursement for genetic and molecular testing

• Amanda Bridges
• November 13, 2017
• Drugs
• No Comments

Effective November 1, 2017, United Healthcare is implementing an online Prior Authorization program for genetic and molecular testing The Genentech products affected are: ALECENSA® (alectinib) COTELLIC® (cobimetinib) Herceptin® (trastuzumab) KADCYLA® (ado-trastuzumab emtansine) PERJETA® (pertuzumab) Tarceva® (erlotinib) TECENTRIQ® (atezolizumab) VENCLEXTA® (venetoclax) ZELBORAF® (vemurafenib) Additional information can be obtained at https://www.uhcprovider.com/en/prior-auth-advancenotification/genetic-molecular-lab.html ©2017 Genentech USA, Inc. So. San…

ZELBORAF® (Vemurafenib) is Now FDA Approved

• Amanda Bridges
• November 13, 2017
• Drugs
• No Comments

Genentech is excited to share the news of a new FDA approval. ZELBORAF® (Vemurafenib) is NOW FDA APPROVED for patients with Erdheim-Chester disease (ECD) with BRAF V600 mutation.  ZELBORAF is not indicated for treatment of patients with wild-type BRAF ECD. ECD is a rare, serious blood disease characterized by the abnormal multiplication of certain white…

U.S. Food and Drug Administration Expands Approval of Sprycel® (dasatinib) to Include Treatment of Children with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase

• FLASCO
• November 10, 2017
• Drugs
• No Comments

–Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has expanded the indication for Sprycel ® (dasatinib) tablets to include the treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).1 This approval for Sprycel in pediatric patients with Ph+ CML in chronic phase was granted under priority review, and the indication received…

FDA approves new treatment for adults with mantle cell lymphoma

• FLASCO
• November 10, 2017
• Drugs
• No Comments

The U.S. Food and Drug Administration today granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma is a particularly aggressive cancer,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the…

FDA approves Brentuximab vedotin for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma

• FLASCO
• November 10, 2017
• Drugs
• No Comments

On November 9, 2017, the Food and Drug Administration granted regular approval to brentuximab vedotin (ADCETRIS, Seattle Genetics, Inc.) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy. Approval was based on a phase 3, randomized, open-label, multicenter clinical…

FDA clears common blood cell count test that offers faster results for patients and providers

• FLASCO
• November 10, 2017
• Drugs
• No Comments

The U.S. Food and Drug Administration today cleared a complete blood cell count (CBC) test that, based on its categorization, can be run in more health care settings, including physicians’ offices, clinics or other types of health care facilities, by a wider range of personnel (e.g. support staff). This broadened test access will allow for…

FDA approves first treatment for certain patients with Erdheim-Chester Disease, a rare blood cancer

• FLASCO
• November 10, 2017
• Drugs
• No Comments

The U.S. Food and Drug Administration today expanded the approval of Zelboraf (vemurafenib) to include the treatment of certain adult patients with Erdheim-Chester Disease (ECD), a rare cancer of the blood. Zelboraf is indicated to treat patients whose cancer cells have a specific genetic mutation known as BRAF V600. This is the first FDA-approved treatment…

FDA Approves Merck’s Prevymis (letermovir) – first drug for prophylaxis of cytomegalovirus infection and disease in bone marrow transplant patients

• FLASCO
• November 10, 2017
• Drugs
• No Comments

FDA approved Prevymis (letermovir) tablets and injection, the first drug indicated to help prevent CMV (cytomegalovirus) infection and disease in adults who have been exposed to CMV and have received an allogeneic hematopoietic stem cell (bone marrow) transplant (HSCT). Among the more than 27,000 allogeneic HSCTs performed each year worldwide (including approximately 8,500 transplants in…

FDA approves Roche’s Alecensa® (alectinib) as first-line treatment for people with specific type of lung cancer

• Amanda Bridges
• November 7, 2017
• Drugs
• No Comments

The FDA has approved the supplemental New Drug Application (sNDA) for Alecensa® (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. The Genentech press release including Important Safety Information is linked here. ALK-positive NSCLC is often found in younger people, who…

State Cancer Drug Legislative Implications

• Amanda Bridges
• November 7, 2017
• Drugs
• No Comments

Will state legislation affect your market access strategies for your current or future products? How do payers interpret the legislation into organizational coverage decisions? Each state’s legislative provisions can vary related to content and subsequently the implications for a payer’s interpretation and application to drug coverage decisions. DK Pierce is known for its deep-dive knowledge…

The US Food and Drug Administration (FDA) has Approved Verzenio™ (abemaciclib)

• Amanda Bridges
• October 17, 2017
• Drugs
• No Comments

Click here for full Prescribing Information and see below for Indications and Important Safety Information for Verzenio.   Dosing Regimen Tablet Strength Quantity NDC* Days of Therapy per Pack Verzenio 7-Day Dose Pack 200 mg dose pack (one 200 mg tablet) 200 mg 14 tablets 00002-6216-54 7 days twice daily 150 mg dose pack (one…

Genentech is pleased to announce the FDA approval of RITUXAN HYCELA for FL, DLBCL, and CLL

• Amanda Bridges
• October 17, 2017
• Drugs
• No Comments

INDICATIONS RITUXAN HYCELA™ (rituximab/hyaluronidase human) is indicated for the treatment of adult patients with: Relapsed or refractory, follicular lymphoma (FL) as a single agent Previously untreated follicular lymphoma in combination with first-line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy Non-progressing (including stable disease) follicular lymphoma…

FDA Approves Lilly’s Abemaciclib for HR+/HER2- Breast Cancer

• FLASCO
• September 30, 2017
• Drugs
• No Comments

The FDA approved abemaciclib (Verzenio) for use in combination with fulvestrant in women with HR+/HER2- advanced breast cancer with disease progression following endocrine therapy. The CDK4/6 inhibitor has also been approved as a monotherapy for patients with HR+/HER2- breast cancer with metastatic disease who have previously received endocrine therapy and chemotherapy. Support for the combination indication…

Combination of Optune® with Temozolomide Demonstrates Unprecedented Five-Year Survival for Newly Diagnosed Glioblastoma Patients

• Amanda Bridges
• September 29, 2017
• Drugs
• No Comments

BROUGHT TO YOU BY A 100% FLASCO MEMBERSHIP PARTNER Newly diagnosed glioblastoma patients treated with Optune plus temozolomide were able to maintain quality of life for longer compared to those treated with temozolomide alone Data presented today as a late-breaking oral presentation at the American Society for Radiation Oncology’s 2017 Annual Meeting HELIER, Jersey–(BUSINESS WIRE)–…

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Previously Treated Patients with Recurrent Locally Advanced, Metastatic Gastric or Gastroesophageal Junction Cancer Whose Tumors Express PD-L1

• Amanda Bridges
• September 29, 2017
• Drugs
• No Comments

FDA Approves Pembrolizumab for PD-L1+ Gastric Cancer

• FLASCO
• September 24, 2017
• Drugs
• No Comments

Click here to read corporate press release.   The FDA has approved pembrolizumab (Keytruda) for the treatment of patients with PD-L1–positive recurrent or advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received 2 or more lines of chemotherapy, including fluoropyrimidine- and platinum-containing chemotherapy, and, if appropriate, HER2/neu-targeted therapy. The approval is based on findings…

FDA Approves Lower Dose of Cabazitaxel for Prostate Cancer

• FLASCO
• September 24, 2017
• Drugs
• No Comments

On September 14, 2017, the U.S. Food and Drug Administration approved a lower dose of cabazitaxel (20 mg/m2 every 3 weeks) (JEVTANA®, Sanofi-Aventis) in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen.  Cabazitaxel (25 mg/m2 every  3 weeks) was approved for this indication in 2010….

FDA Approves New Treatment for Adults with Relapsed Follicular Lymphoma

• FLASCO
• September 14, 2017
• Drugs
• No Comments

The U.S. Food and Drug Administration today granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies. “For patients with relapsed follicular lymphoma, the cancer often comes back even after multiple treatments,” said Richard Pazdur, M.D., director of…

FDA Approves First Biosimilar for the Treatment of Cancer

• FLASCO
• September 14, 2017
• Drugs
• No Comments

The U.S. Food and Drug Administration today approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer. “Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high,…

Faslodex in Metastic Breast Cancer is Hosting a Life Virtual Launchcast

• Amanda Bridges
• September 14, 2017
• Drugs
• No Comments

Brought to you by a FLASCO Corporate Member!

FDA Approves Mylotarg for Treatment of Acute Myeloid Leukemia

• FLASCO
• September 6, 2017
• Drugs
• No Comments

The U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML). The FDA also approved Mylotarg for the treatment of patients aged 2 years and older with CD33-positive AML who have experienced a relapse or who…

FDA approves Novartis’ CAR-T cell therapy Kymriah for acute lymphoblastic leukemia

• FLASCO
• August 31, 2017
• Drugs
• No Comments

The FDA on Wednesday announced the approval of Novartis’ CAR-T cell therapy Kymriah (tisagenlecleucel) for certain paediatric and young adult patients with acute lymphoblastic leukaemia (ALL), marking what the agency said is the first clearance of a gene therapy in the US. “We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells…

New Initial Monotherapy for Women with Advanced Breast Cancer Now Available

• FLASCO
• August 29, 2017
• Drugs
• No Comments

AstraZeneca is pleased to announce on August 25, 2017, the FDA has approved FASLODEX® (fulvestrant) for earlier use in the treatment journey, as initial monotherapy for postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer not previously treated with endocrine therapy. The new indication offers another option…

FDA Approves inotuzumab ozogamicin For Relapsed or Refractory B-cell Precursor ALL

• FLASCO
• August 17, 2017
• Drugs
• No Comments

On Aug. 17, 2017, the U.S. Food and Drug Administration approved inotuzumab ozogamicin (BESPONSA, Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The approval was based on data from INO-VATE ALL (NCT01564784), a randomized (1:1), open label, international, multicenter study…

FDA approves olaparib tablets for maintenance treatment in ovarian cancer

• FLASCO
• August 17, 2017
• Drugs
• No Comments

On Aug. 17, 2017, the U.S. Food and Drug Administration granted regular approval to olaparib tablets (Lynparza, AstraZeneca) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. With the addition of the new indication, a tablet…

FDA Approves liposome-encapsulated combination of daunorubicin-cytarabine for adults with some types of poor prognosis AML

• FLASCO
• August 3, 2017
• Drugs
• No Comments

On August 3, 2017, the U.S. Food and Drug Administration granted regular approval to a liposome-encapsulated combination of daunorubicin and cytarabine (VYXEOS, Jazz Pharmaceuticals, Inc.) for the treatment of adults with newly-diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC), two types of AML having a poor prognosis. This is the first FDA-approved treatment…

FDA Expands ibrutinib Indications to Chronic GVHD

• FLASCO
• August 2, 2017
• Drugs
• No Comments

On August 2, 2017, the U.S. Food and Drug Administration approved ibrutinib (Imbruvica, Pharmacyclics LLC) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. This is the first FDA-approved therapy for the treatment of cGVHD. Approval was based on Study PCYC-1129-CA…

FDA Grants Nivolumab Accelerated Approval for MSI-H or dMMR Colorectal Cancer

• FLASCO
• August 1, 2017
• Drugs
• No Comments

On July 31, 2017, the U.S. Food and Drug Administration granted accelerated approval to nivolumab (OPDIVO, Bristol-Myers Squibb Company) for the treatment of patients 12 years and older with mismatch repair deficient (dMMR) and microsatellite instability high (MSI-H) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. The approval was…

FDA Granted Regular Approval to Enasidenib for the Treatment of Relapsed or Refractory AML

• FLASCO
• August 1, 2017
• Drugs
• No Comments

On August 1, 2017, the U.S. Food and Drug Administration granted regular approval to enasidenib (IDHIFA, Celgene Corp.) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test. This is the first FDA approval for relapsed or refractory AML specifically…

U.S. Food and Drug Administration Expands Approval of Yervoy® (ipilimumab) to Include Pediatric Patients 12 Years and Older with Unresectable or Metastatic Melanoma

• FLASCO
• July 27, 2017
• Drugs
• No Comments

The U.S. Food and Drug Administration (FDA) has expanded the indication for Brisol-Myers Squibb’s Yervoy ® (ipilimumab) injection for intravenous use to now include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older. Yervoy was evaluated in two trials of pediatric patients: a dose-finding study in 33 patients aged two to 21 years…

FDA Clears Puma Biotechnology’s Nerlynx for Extended Adjuvant Treatment of HER2-positive Early-Stage Breast Cancer

• FLASCO
• July 20, 2017
• Drugs
• No Comments

On July 17, 2017, the U.S. Food and Drug Administration approved neratinib (NERLYNX, Puma Biotechnology, Inc.) for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy. Approval was based on the ExteNET trial (NCT00878709), a multicenter, randomized, double-blind, placebo-controlled trial of neratinib following adjuvant trastuzumab treatment….

FDA Approves New Drug to Treat Adults with Chronic Hepatitis C Virus genotypes 1-6 without Cirrhosis or with Mild irrhosis

• FLASCO
• July 20, 2017
• Drugs
• No Comments

The U.S. Food and Drug Administration today approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis. Vosevi is a fixed-dose, combination tablet containing two previously approved drugs – sofosbuvir and velpatasvir – and a new drug, voxilaprevir. Vosevi is the first treatment approved…

FDA Approves New Treatment for Sickle Cell Disease

• FLASCO
• July 13, 2017
• Drugs
• No Comments

The U.S. Food and Drug Administration today approved Endari (L-glutamine oral powder) for patients age five years and older with sickle cell disease to reduce severe complications associated with the blood disorder. “Endari is the first treatment approved for patients with sickle cell disease in almost 20 years,” said Richard Pazdur, M.D., acting director of…

FDA Grants Full Approval for BLINCYTO® (blinatumomab) to Treat Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia in Adults and Children

• FLASCO
• July 13, 2017
• Drugs
• No Comments

Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) to include overall survival (OS) data from the Phase 3 TOWER study. The approval converts BLINCYTO’s accelerated approval to a full approval. The sBLA approval also included data from the Phase 2 ALCANTARA study…

FDA allows marketing of test to aid in the detection of certain leukemias and lymphomas

• FLASCO
• July 6, 2017
• Drugs
• No Comments

The U.S. Food and Drug Administration today allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN). “This represents a…

FDA clears expanded use of cooling cap to reduce hair loss during chemotherapy

• FLASCO
• July 6, 2017
• Drugs
• No Comments

The U.S. Food and Drug Administration cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss (alopecia) during chemotherapy. This is the first cooling cap cleared by the agency for use in cancer patients with solid tumors. “We are pleased to expand the use of this product for cancer patients…

FDA granted marketing approval to the Praxis Extended RAS Panel

• FLASCO
• July 6, 2017
• Drugs
• No Comments

On June 29, 2017, the U.S. Food and Drug Administration granted marketing approval to the Praxis Extended RAS Panel (Illumina, Inc.), a next generation sequencing (NGS) test to detect certain genetic mutations in RAS genes in tumor samples of patients with metastatic colorectal cancer (mCRC). The test is used to aid in the identification of…

FDA grants regular approval to dabrafenib and trametinib combination for metastatic NSCLC with BRAF V600E mutation

• FLASCO
• June 23, 2017
• Drugs
• No Comments

On June 22, 2017, the U.S. Food and Drug Administration granted regular approvals to dabrafenib and trametinib (TAFINLAR® and MEKINIST®, Novartis Pharmaceuticals Inc.) administered in combination for patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. These are the first FDA approvals specifically for treatment of…

FDA Approves Drug to Visualize Malignant Tissue During Surgery – Drug Information Update

• FLASCO
• June 8, 2017
• Drugs
• No Comments

FDA has approved Gleolan (aminolevulinic acid hydrochloride, ALA HCl), an optical imaging agent indicated in patients with gliomas (suspected World Health Organization grades III or IV on preoperative imaging) as an adjunct for visualization of malignant tissue during glioma surgery. Gleolan is the first fluorescing agent approved for use with gliomas.   Three prospective studies…

FDA Broadens ceritinib Indication to Previously Untreated ALK-Positive Metastatic NSCLC

• FLASCO
• May 30, 2017
• Drugs
• No Comments

On May 26, 2017, the U.S. Food and Drug Administration granted regular approval to ceritinib (ZYKADIA, Novartis Pharmaceuticals Corp.) for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. In April 2014, ceritinib received accelerated approval for patients with ALK-positive metastatic NSCLC whose…

KEYTRUDA: Approved for use regardless of BRAF status

• FLASCO
• May 25, 2017
• Drugs
• No Comments

Merck is pleased to announce that KEYTRUDA is now approved for 200-mg fixed-dose administration in patients with unresectable or metastatic melanoma click here to read more.

FDA Approves First Cancer Treatment For Any Solid Tumor With A Specific Genetic Feature – microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

• FLASCO
• May 25, 2017
• Drugs
• No Comments

On May 23, 2017, the U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co.) for adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or with MSI-H…

Updates to Humana Medicare Part D Prior Authorization Policy for XTANDI Expands Access

• Amanda Bridges
• May 18, 2017
• Drugs
• No Comments

Pebrolizumab (Keytruda): Advanced or Metastatic Urothelial Carcinoma

• FLASCO
• May 18, 2017
• Drugs
• No Comments

Click here to read the corporate announcement.   On May 18, 2017, the U.S. Food and Drug Administration granted regular approval to pembrolizumab (KEYTRUDA, Merck and Co., Inc.) for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment…

Pembrolizumab (KEYTRUDA) for classical Hodgkin lymphoma

• FLASCO
• May 18, 2017
• Drugs
• No Comments

On March 14, 2017, The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA), Merck and Co., Inc.) for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those who have relapsed after three or more prior lines of therapy. Approval was based on data from 210 adult…

FDA grants accelerated approval to Merck’s KEYTRUDA® in combination with pemetrexed and carboplatin for initial treatment of metastatic non-squamous NSCLC

• FLASCO
• May 11, 2017
• Drugs
• No Comments

Read Merck’s announcement. Click here for corporate press release On May 10, 2017, the U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA® , Merck and Co., Inc.) in combination with pemetrexed and carboplatin for the treatment of patients with previously untreated metastatic non-squamous non-small cell lung cancer (NSCLC).   Approval was based…

FDA Grants Accelerated Approval to EMD Serono’s (BAVENCIO) avelumab for Urothelial Carcinoma

• FLASCO
• May 10, 2017
• Drugs
• No Comments

On May 9, 2017, the U.S. Food and Drug Administration granted accelerated approval to avelumab (BAVENCIO, EMD Serono, Inc.) for patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Approval was based on data from an open-label, single…

Novartis Receives FDA Approval for Rydapt® in Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia (AML) and Three Types of Systemic Mastocytosis (SM)

• FLASCO
• May 4, 2017
• Drugs
• No Comments

On April 28, 2017, the U.S. Food and Drug Administration approved midostaurin (RYDAPT, Novartis Pharmaceuticals Corp.) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive (FLT3+), as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. The FDA also approved…

Takeda Announces FDA Accelerated Approval of ALUNBRIGTM (brigatinib)

• FLASCO
• May 4, 2017
• Drugs
• No Comments

On April 28, 2017, the U.S. Food and Drug Administration granted accelerated approval to brigatinib (ALUNBRIG tablets, Takeda Pharmaceutical Company Limited, through its wholly owned subsidiary ARIAD Pharmaceuticals, Inc.) for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. Approval…

AstraZeneca Immunotherapy Wins First Approval In Bladder Cancer

• FLASCO
• May 4, 2017
• Drugs
• No Comments

Learn More at https://www.imfinzi.com/    On May 1, 2017, the U.S. Food and Drug Administration granted accelerated approval to durvalumab (IMFINZI, AstraZeneca UK Limited) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or…

FDA Approves Regorafenib for Liver Cancer

• FLASCO
• April 27, 2017
• Drugs
• No Comments

On April 27, 2017 the U.S. Food and Drug Administration expanded the indications of regorafenib (STIVARGA, Bayer HealthCare Pharmaceuticals Inc.) to include the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Approval was based on an international, multicenter, randomized, double-blind, placebo-controlled trial of 573 patients with Child-Pugh A and…

FDA Approves Cancer Immunotherapy TECENTRIQ as Initial Treatment for Certain People with Advanced Bladder Cancer

• Amanda Bridges
• April 18, 2017
• Drugs
• No Comments

The FDA approved Tecentriq (atezolizumab) as a first-line treatment for people with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin chemotherapy. The Genentech press release including Important Safety Information is linked here. This approval is important news for a number of reasons: According to the American Cancer Society, it is…

FDA removes Risk Evaluation Management Strategies (REMS) for ESAs

• FLASCO
• April 13, 2017
• Drugs
• No Comments

U.S. Food and Drug Administration removed the Risk Evaluation and Mitigation Strategy (REMS) requirements for the use of Epogen/Procrit and Aranesp to treat patients with anemia due to associated myelosuppressive chemotherapy. Below is the Agency’s announcement regarding this action: Epoetin alfa and darbepoetin alfa are Erythropoiesis-Stimulating Agents (ESAs), approved for the treatment of anemia (low…