Drugs

FDA granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia

• FLASCO
• March 30, 2018
• Drugs
• No Comments

On March 29, 2018, the Food and Drug Administration granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Approval was based on the open…

Nilotinib Approved to Treat Pediatric Patients with Leukemia

• FLASCO
• March 26, 2018
• Drugs
• No Comments

The FDA approved an expanded indication for nilotinib (Tasigna) as a first- and second-line treatment for pediatric patients 1 year and older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP), according to a press release. Nilotinib is currently indicated to treat both adults and pediatric patients with newly-diagnosed Ph+ CML-CP. It is…

NCCN Recommends Regorafenib Dose Escalation in Metastatic CRC

• Amanda Bridges
• March 20, 2018
• Drugs
• No Comments

The NCCN guidelines were updated. CRC now includes the new dose escalation for Stivarga as a result of the ReDos study.  Read more at OncLive.com here http://www.onclive.com/web-exclusives/nccn-recommends-regorafenib-dose-escalation-in-metastatic-crc.

FDA expands approval of Adcetris for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy

• FLASCO
• March 20, 2018
• Drugs
• No Comments

The U.S. Food and Drug Administration today approved Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy. “Today’s approval represents an improvement in the initial treatment regimens of advanced Hodgkin lymphoma that were introduced into clinical practice more than 40 years ago,”…

FDA Approves sBLA Updating Nivolumab Dosing Schedule Across Indications

• FLASCO
• March 8, 2018
• Drugs
• No Comments

On March 6, Bristol-Myers Squibb announced the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) updating the nivolumab (Opdivo) dosing schedule to include 480 mg infused every 4 weeks for a majority of approved indications. This approval will provide health-care professionals the flexibility to customize patient care with the option of using the…

FDA Approval of New Indication for Verzenio™

• Amanda Bridges
• March 2, 2018
• Drugs
• No Comments

February 26, 2018 – The US Food and Drug Administration (FDA) approved a new indication for Verzenio™ (abemaciclib 50, 100, 150, 200 mg tablets). See below for the Indication and Important Safety Information and click to access the full Prescribing Information for Verzenio.    Dosing Regimen Tablet Strength Quantity NDC* Days of Therapy per Pack Verzenio 7-Day Dose…

FDA approves Lilly’s abemaciclib as initial therapy for HR-positive, HER2-negative metastatic breast cancer

• FLASCO
• February 27, 2018
• Drugs
• No Comments

On February 26, 2018, the Food and Drug Administration approved abemaciclib (VERZENIO™, Eli Lilly and Company) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Approval was based on MONARCH 3, a randomized (2:1), double-blinded,…

FDA expands approval of AstraZeneca’s Imfinzi to reduce the risk of non-small cell lung cancer progressing

• FLASCO
• February 19, 2018
• Drugs
• No Comments

The U.S. Food and Drug Administration today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation). “This is the first treatment approved for stage III…

The U.S. Food and Drug Administration approved Janssen’s Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant).

• FLASCO
• February 14, 2018
• Drugs
• No Comments

The U.S. Food and Drug Administration approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer. “The FDA evaluates a variety of methods that measure a drug’s…

FDA approves new treatment for certain digestive tract cancers

• FLASCO
• January 28, 2018
• Drugs
• No Comments

The U.S. Food and Drug Administration  approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs. Lutathera is indicated for adult…

FDA approves new indication for Gilotrif® in EGFR mutation-positive NSCLC

• Amanda Bridges
• January 18, 2018
• Drugs
• No Comments

FDA Warns About Anaphylaxis, Anaphylactic Shock With Use Of Rolapitant In Patients With Cancer.

• FLASCO
• January 18, 2018
• Drugs
• No Comments

A warning about anaphylaxis, anaphylactic shock, and other hypersensitivity reactions occurring with the use of rolapitant (Varubi, Tesaro Inc) in patients with cancer has been highlighted by the US Food and Drug Administration in a MedWatch bulletin. Rolapitant is a substance/ neurokinin receptor antagonist indicated for the prevention of delayed nausea and vomiting associated with cancer…

FDA Approves Addition Of Overall Survival Data To KYPROLIS® (carfilzomib) Label

• FLASCO
• January 18, 2018
• Drugs
• No Comments

Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to add overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial to the Prescribing Information for KYPROLIS® (carfilzomib). Data added to the label demonstrated that KYPROLIS and dexamethasone (Kd) reduced the risk of death by…

Teva Announces U.S. FDA Approval of TRISENOX® (arsenic trioxide) Injection for First Line Treatment of Acute Promyelocytic Leukemia

• FLASCO
• January 16, 2018
• Drugs
• No Comments

Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved the use of TRISENOX® (arsenic trioxide) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. The approval was based on…

FDA broadens afatinib indication to previously untreated, metastatic NSCLC with other non-resistant EGFR mutations

• FLASCO
• January 16, 2018
• Drugs
• No Comments

On January 12, 2018, the Food and Drug Administration granted approval to afatinib (Gilotrif, Boehringer Ingelheim Pharmaceutical, Inc.) for a broadened indication in first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test. Approval was based on demonstration…

LYNPARZA® (olaparib) Receives US FDA Approval for a New Indication

• Amanda Bridges
• January 15, 2018
• Drugs
• No Comments

We are excited to announce on January 12, 2018, the FDA approved a new indication for the PARP inhibitor, LYNPARZA® (olaparib), for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC) who have been previously treated with chemotherapy in the neoadjuvant, adjuvant…

FDA approves AstraZeneca’s aparib for germline BRCA-mutated metastatic breast cancer

• FLASCO
• January 12, 2018
• Drugs
• No Comments

On January 12, 2018, the Food and Drug Administration granted regular approval to olaparib tablets (Lynparza, AstraZeneca Pharmaceuticals LP), a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic…

Announcing a New Indication for a PERJETA

• FLASCO
• January 8, 2018
• Drugs
• No Comments

Genentech is excited to share the news of the FDA approval of PERJETA in combination with trastuzumab and chemotherapy as: ·       Neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast…

FDA Approves Denosumab (Xgeva) for the Prevention of Skeletal-Related Events in Patients With Multiple Myeloma

• FLASCO
• January 8, 2018
• Drugs
• No Comments

The FDA has approved denosumab (Xgeva) for the prevention of skeletal-related events (SREs) in patients with multiple myeloma, according to Amgen, the developer of the RANK ligand inhibitor. The approval is based on data from the phase III 482 study, which were presented at the 16th International Myeloma Workshop in New Delhi. In the trial,…

FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response

• FLASCO
• December 26, 2017
• Drugs
• No Comments

The U.S. Food and Drug Administration today updated the product label for the cancer drug Tasigna (nilotinib) to include information for providers about how to discontinue the drug in certain patients. Tasigna, first approved by the FDA in 2007, is indicated for the treatment of patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML)….

Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab)

• Amanda Bridges
• December 21, 2017
• Drugs
• No Comments

Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) as Adjuvant Therapy in Patients with Completely Resected Melanoma with Lymph Node Involvement or Metastatic Disease. Please click here for an announcement from Bristol-Myers Squibb.

The FDA Approved Perjeta® (pertuzumab)

• Amanda Bridges
• December 21, 2017
• Drugs
• No Comments

The FDA recently approved Perjeta® (pertuzumab), in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer (EBC) at high risk of recurrence. The Genentech press release including Important Safety Information is linked here. This approval is important because: It is based on results of the Phase…

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
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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…