Drugs

NCCN released recommendations for the use of hematopoietic growth factors during the COVID-19 pandemic

• Katrina Williams
• April 16, 2020
• Drugs
• No Comments

In response to the COVID-19 pandemic, National Comprehensive Cancer Network® (NCCN®) has released recommendations for the use of hematopoietic growth factors during this time. The recommendations have been posted on NCCN’s website, along with other COVID-19 Resources: Hematopoietic Growth Factors Recommendations NCCN COVID-19 Resources NCCN noted that for acute myeloid leukemia (AML) and myelodysplastic syndromes…

FDA approved mitomycin (JELMYTO™, UroGen Pharma) for adult patients with low-grade upper tract urothelial cancer (LG-UTUC)

• Katrina Williams
• April 16, 2020
• Drugs
• No Comments

Food and Drug Administration approved mitomycin (JELMYTO™, UroGen Pharma) for adult patients with low-grade upper tract urothelial cancer (LG-UTUC). More Information. April 15, 2020 https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-low-grade-upper-tract-urothelial-cancer  Hematology/Oncology (Cancer) Approvals & Safety Notifications    https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications

FDA approved selumetinib (KOSELUGO®, AstraZeneca) for pediatric patients

• Katrina Williams
• April 13, 2020
• Drugs
• No Comments

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…

Hematology/Oncology (Cancer) Approvals & Safety Notifications

• Amanda Bridges
• April 9, 2020
• Drugs
• No Comments

FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products. 2020 Food and Drug Administration approved encorafenib (BRAFTOVI, Array BioPharma Inc.) in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer…

FDA approves encorafenib in combination with cetuximab for metastatic colorectal cancer with a BRAF V600E mutation

• Amanda Bridges
• April 9, 2020
• Drugs
• No Comments

On April 8, 2020, the Food and Drug Administration approved encorafenib (BRAFTOVI, Array BioPharma Inc.) in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, detected by an FDA-approved test, after prior therapy. Efficacy was evaluated in a randomized, active-controlled, open-label, multicenter trial (BEACON CRC;…

FDA approved luspatercept-aamt (REBLOZYL, Celgene Corporation) for the treatment of anemia

• Katrina Williams
• April 6, 2020
• Drugs
• No Comments

Food and Drug Administration approved luspatercept-aamt (REBLOZYL, Celgene Corporation) for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis…

Food and Drug Administration approved durvalumab (IMFINZI®, AstraZeneca) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC)

• Katrina Williams
• March 30, 2020
• Drugs
• No Comments

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…

FDA approval for Neratinib to Treat HER2-Positive Metastatic Breast Cancer

• Katrina Williams
• March 23, 2020
• Drugs
• No Comments

Great news!  Puma Biotechnology received U.S. FDA approval for Neratinib to Treat HER2-Positive Metastatic Breast Cancer.  The sNDA approval was based on results of the Phase III NALA trial, a randomized controlled trial of neratinib plus capecitabine in patients with HER2-positive metastatic breast cancer who have received two or more prior anti-HER2-based regimens. Adam M….

Taiho Oncology Announcement

• Katrina Williams
• February 12, 2020
• Drugs
• No Comments

On behalf of Taiho Oncology, Inc., we are pleased to inform you that a corporate press release, “Astex Pharmaceuticals announces U.S. Food and Drug Administration (FDA) acceptance for review of an NDA for the combination oral hypomethylating agent cedazuridine and decitabine (ASTX727 or oral C-DEC), for the treatment of MDS and CMML” has been issued…

FDA grants approval for TAZVERIK

• Katrina Williams
• January 29, 2020
• Drugs
• No Comments

Epizyme announces that U.S. Food and Drug Administration (FDA) has granted accelerated approval of TAZVERIK (tazemetostat) for the treatment of adults and pediatric patients age 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for resection, based on overall response rate and duration of response in a Phase 2 clinical trial.  You…

FDA approves Keytruda for treatment of patients with BCG

• Katrina Williams
• January 29, 2020
• Drugs
• No Comments

Merck is pleased to announce that KEYTRUDA® (pembrolizumab) has been approved by the FDA for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. PD-L1 diagnostic testing is not…

FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer

• Katrina Williams
• January 24, 2020
• Drugs
• No Comments

Today, the U.S. Food and Drug Administration granted accelerated approval to Tazverik (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic (when cancer cells spread to other parts of the body) or locally advanced (when cancer has grown outside the organ it started in, but has not yet…

FDA approves new therapy to treat a rare mutation in patients with gastrointestinal stromal tumors

• Katrina Williams
• January 10, 2020
• Drugs
• No Comments

Today, the U.S. Food and Drug Administration approved Ayvakit (avapritinib) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) gastrointestinal stromal tumor (GIST) – a type of tumor that occurs in the gastrointestinal tract, most commonly in the stomach…

FDA approved pembrolizumab (KEYTRUDA, Merck & Co. Inc.) for the treatment of patients with Bacillus Calmette-Guerin (BCG)

• Katrina Williams
• January 8, 2020
• Drugs
• No Comments

Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co. Inc.) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. More Information. January 8, 2020 https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-bcg-unresponsive-high-risk-non-muscle-invasive-bladder-cancer  Hematology/Oncology (Cancer)…

FDA grants approval to fam-trastuzumab deruxtecan-nxki (ENHERTU®)

• Katrina Williams
• December 23, 2019
• Drugs
• No Comments

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…

FDA approved enzalutamide (XTANDI, Astellas Pharma Inc.)

• Katrina Williams
• December 17, 2019
• Drugs
• No Comments

FDA approved enzalutamide (XTANDI, Astellas Pharma Inc.) for patients with metastatic castration-sensitive prostate cancer (mCSPC). More Information. December 16, 2019 https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-enzalutamide-metastatic-castration-sensitive-prostate-cancer  Hematology/Oncology (Cancer) Approvals & Safety Notifications    https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications  

Info on accelerated approval for BRUKINSA

• Katrina Williams
• December 11, 2019
• Drugs
• No Comments

Please be aware NCCN has recently updated their Oncology Guidelines for Mantel Cell Leukemia (MCL) based on the accelerated approval for BRUKINSA. NCCN has provided BRUKINSA (zanubrutinib) in R/R MCL with a Level 2A Preferred evidence listing, comparable to other BTKi in the class. This is the link to the NCCN main website, https://www.nccn.org/professionals/physician_gls/default.aspx . 

CALQUENCE® (acalabrutinib) Receives US FDA Approval for New Indication

• Amanda Bridges
• December 3, 2019
• Drugs
• No Comments

The US Food and Drug Administration (FDA) has approved CALQUENCE® (acalabrutinib) capsules for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CALQUENCE for CLL was granted Breakthrough Therapy Designation by the FDA, and the approval was granted under the FDA’s Real Time Oncology Review (RTOR) and newly established…

Introducing BRUKINSA™ (zanubrutinib)—the new BTK inhibitor

• Amanda Bridges
• November 18, 2019
• Drugs
• No Comments

FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumor shrinkage For Immediate Release: November 14, 2019 Today, the U.S. Food and Drug Administration granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients with mantle cell lymphoma…

FDA Approved REBLOZYL® (luspatercept-aamt)

• Katrina Williams
• November 15, 2019
• Drugs
• No Comments

The US Food and Drug Administration has recently approved REBLOZYL® (luspatercept-aamt), the first and only erythroid maturation agent (EMA) indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require…

Alexion Receives FDA Approval For ULTOMIRIS® (Ravulizumab-Cwvz) For Atypical Hemolytic Uremic Syndrome (AHUS)

• Katrina Williams
• November 3, 2019
• Drugs
• No Comments

October 18, 2019 at 7:45 PM EDT PDF Version – At 26 weeks, 54% of adults and 71% of children treated with ULTOMIRIS demonstrated Complete Thrombotic Microangiopathy (TMA) Response – BOSTON–(BUSINESS WIRE)–Oct. 18, 2019– Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that the U.S. Food and Drug Administration (FDA) approved ULTOMIRIS® (ravulizumab-cwvz) for the treatment of atypical hemolytic uremic syndrome (aHUS)…

CMS coverage changes regarding CAR T Therapies

• Katrina Williams
• September 3, 2019
• Drugs
• No Comments

Recently, the Centers for Medicare and Medicaid Services (CMS) posted two announcements which impacts payment and coverage  for Chimeric Antigen Receptor T-Cell (CAR T) Therapies.  This email will provide a brief summary of the Fiscal Year (FY) 2020 Inpatient Prospective Payment System (IPPS) Final Rule, and the National Coverage Determination (NCD) for CAR T cell therapy…

Approval of a new product for myelofibrosis

• Amanda Bridges
• August 22, 2019
• Drugs
• No Comments

Celgene is pleased to inform you of the US Food and Drug Administration’s recent approval of INREBIC® (fedratinib) capsules, a product from Celgene indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). Attached please find an announcement of this recent approval. http://cloud.info-celgene.com/inrebicpro INDICATION…

Announcing a New Genentech Therapy for ROS1+ mNSCLC and NTRK+ Solid Tumors

• Amanda Bridges
• August 22, 2019
• Drugs
• No Comments

Dear Healthcare Professional:  Genentech is excited to share the news of a new FDA approval. ROZLYTREK™ (entrectinib) is now FDA approved for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. ROZLYTREK is also FDA approved for the treatment of adult and pediatric patients 12 years of age…

FDA Approves First Therapy for Rare Joint Tumor

• FLASCO
• August 5, 2019
• Drugs
• No Comments

The U.S. Food and Drug Administration granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery.   “TGCT can cause debilitating symptoms for patients such as pain, stiffness and limitation of movement….

FDA approves pembrolizumab for advanced esophageal squamous cell cancer

• FLASCO
• July 31, 2019
• Drugs
• No Comments

On July 30, 2019, the Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck) for patients with recurrent, locally advanced or metastatic, squamous cell carcinoma of the esophagus (ESCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10), as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy….

FDA approves darolutamide for non-metastatic castration-resistant prostate cancer

• FLASCO
• July 31, 2019
• Drugs
• No Comments

On July 30, 2019, the Food and Drug Administration approved darolutamide (NUBEQA, Bayer HealthCare Pharmaceuticals Inc.) for non-metastatic castration-resistant prostate cancer. Approval was based on ARAMIS (NCT02200614), a multicenter, double-blind, placebo-controlled clinical trial in 1,509 patients with non-metastatic castration resistant prostate cancer. Patients were randomized (2:1) to receive either 600 mg darolutamide orally twice daily (n=955)…

FDA approves Ruxience (rituximab-pvvr), biosimilar to Rituxan (rituximab)

• FLASCO
• July 24, 2019
• Drugs
• No Comments

The U.S Food and Drug Administration (FDA) today approved Ruxience (rituximab-pvvr), a biosimilar to U.S.-licensed 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, and CD20-positive Chronic Lymphocytic Leukemia (CLL) in combination with chemotherapy. Ruxience is also the…

FDA grants accelerated approval to selinexor for multiple myeloma

• FLASCO
• July 10, 2019
• Drugs
• No Comments

On July 3, 2019, the Food and Drug Administration granted accelerated approval to selinexor (XPOVIO, Karyopharm Therapeutics) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents,…

FDA approves selinexor for multiple myeloma

• FLASCO
• July 3, 2019
• Drugs
• No Comments

On July 3, 2019, the Food and Drug Administration granted accelerated approval to selinexor (XPOVIO, Karyopharm Therapeutics) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents,…

Change to the Herceptin HYLECTA™ (trastuzumab and hyaluronidase-oysk) J-code

• Katrina Williams
• July 3, 2019
• Drugs
• No Comments

Centers for Medicare & Medicaid Services (CMS) has made a change to the Herceptin HYLECTA™ (trastuzumab and hyaluronidase-oysk) J-code and has assigned a permanent J-code.  Effective July 1, 2019 the permanent J-code for Herceptin HYLECTA is J9356. If you have any questions, please reach out to me directly. You may also call Genentech Access Solutions at…

KEYTRUDA(R) (pembrolizumab): Additional Indication

• FLASCO
• July 2, 2019
• Drugs
• No Comments

Merck is pleased to announce that KEYTRUDA has been approved by the FDA for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and…

FDA approves Zirabev (bevacizumab-bvzr), a biosimilar to Avastin (bevacizumab)

• FLASCO
• July 2, 2019
• Drugs
• No Comments

FDA approves Zirabev (bevacizumab-bvzr), a biosimilar to U.S.-licensed Avastin (bevacizumab).   A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-FDA approved biological product, known as a reference product. The biosimilar also must be shown to have no clinically meaningful differences in terms…

Recent update to the TECENTRIQ (atezolizumab) Prescribing Information

• Katrina Williams
• July 2, 2019
• Drugs
• No Comments

There was a recent update to the TECENTRIQ (atezolizumab) Prescribing Information that impacted the dosing regimens for certain indications. This change would allow for either the 840 mg or 1200 mg vials to be used for those indications. Please see below for the NDC information. Updated Prescribing Information Urothelial Carcinoma o   Administer TECENTRIQ as: 840…

FDA approves daratumumab for multiple myeloma ineligible for autologous stem cell transplant

• FLASCO
• June 28, 2019
• Drugs
• No Comments

On June 27, 2019, the Food and Drug Administration approved daratumumab (DARZALEX®, Janssen Biotech, Inc.) in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. Approval was based on MAIA (NCT02252172), an open-label, randomized (1:1), active-controlled phase 3 study, comparing dartumumab (16 mg/kg) in…

FDA Approves Amgen And Allergan’s KANJINTI™ (trastuzumab-anns),

• FLASCO
• June 19, 2019
• Drugs
• No Comments

Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) announced that the U.S. Food and Drug Administration (FDA) has approved KANJINTI™ (trastuzumab-anns) for all approved indications of the reference product, Herceptin® (trastuzumab):  for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. “The FDA approval of KANJINTI is an important milestone for our biosimilars portfolio, providing an additional treatment…

FDA approves pembrolizumab for metastatic small cell lung cancer

• FLASCO
• June 18, 2019
• Drugs
• No Comments

On June 17, 2019, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck) for patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. Efficacy was investigated in 83 patients with SCLC who had disease progression on…

FDA granted accelerated approval to Polivy™

• Katrina Williams
• June 12, 2019
• Drugs
• No Comments

The FDA granted accelerated approval to Polivy™, Genentech’s fifth blood cancer medicine. Polivy (polatuzumab vedotin-piiq) is a first-of-its-kind anti-CD79b antibody-drug conjugate used in combination with bendamustine plus Rituxan (rituximab) for people with diffuse large B-cell lymphoma (DLBCL) whose disease returned after or did not respond to multiple treatment regimens. The Genentech press release including Important…

FDA approves pembrolizumab for first-line treatment of head and neck squamous cell carcinoma

• FLASCO
• June 11, 2019
• Drugs
• No Comments

Read Merck Press Release Here   On June 10, 2019, the Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC). Pembrolizumab was approved for use in combination with platinum and fluorouracil (FU) for all patients and as a…

FDA approves polatuzumab vedotin-piiq

• FLASCO
• June 10, 2019
• Drugs
• No Comments

On June 10, 2019, the Food and Drug Administration granted accelerated approval to polatuzumab vedotin-piiq (POLIVY, Genentech, Inc.), a CD79b-directed antibody-drug conjugate indicated in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies. Approval was based…

FDA Approved VENCLEXTA® (venetoclax tablets)

• Katrina Williams
• June 7, 2019
• Drugs
• No Comments

On May 15, 2019, VENCLEXTA® (venetoclax tablets) was approved by the US Food and Drug Administration (FDA) for the first-line treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). VENCLEXTA is also approved in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia…

FDA approves new treatment for hospital-acquired and ventilator-associated bacterial pneumonia

• FLASCO
• June 5, 2019
• Drugs
• No Comments

The U.S. Food and Drug Administration today approved a new indication for the previously FDA-approved drug, Zerbaxa (ceftolozane and tazobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older. The FDA initially approved Zerbaxa in 2014to treat complicated intra-abdominal infections and for complicated urinary tract infections. “A…

FDA Approves Dalteparin Sodium for VTE in Pediatric Patients

• FLASCO
• May 30, 2019
• Drugs
• No Comments

On May 16, 2019, the Food and Drug Administration approved dalteparin sodium (FRAGMIN®, Pfizer, Inc.) to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients 1 month of age and older. This is the first FDA-approved therapy to treat VTE in pediatric patients. Approval was based on evidence from two prospective, single-arm, multi-center…

FDA approves gilteritinib

• FLASCO
• May 30, 2019
• Drugs
• No Comments

On May 29, 2019, the Food and Drug Administration approved the addition of overall survival data in labeling for gilteritinib (XOSPATA, Astellas Pharma US, Inc.), indicated for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. Approval was based on the ADMIRAL trial…

BAVENCIO® (avelumab) Injection

• Katrina Williams
• May 29, 2019
• Drugs
• No Comments

EMD Serono is pleased to announce that on May 14, 2019 the U.S. Food and Drug Administration (FDA) approved BAVENCIO® (avelumab) Injection 20 mg/mL for a new indication, which is in combination with axitinib.  BAVENCIO is co-developed and co-commercialized by EMD Serono and Pfizer Inc, and axitinib is commercialized by Pfizer Inc. The following information…

FDA approves lenalidomide for follicular and marginal zone lymphoma

• FLASCO
• May 28, 2019
• Drugs
• No Comments

On May 28, 2019, the Food and Drug Administration approved lenalidomide (REVLIMID®, Celgene Corp.) in combination with a rituximab product for previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL). Approval was based on two clinical trials: AUGMENT (NCT01938001) and MAGNIFY (NCT01996865). In AUGMENT, 358 patients with relapsed or refractory FL or…

FDA Approves Ruxolitinib for Steroid-Refractory Acute GVHD

• FLASCO
• May 28, 2019
• Drugs
• No Comments

On May 24, 2019, the Food and Drug Administration approved ruxolitinib (JAKAFI®, Incyte Corporation) for steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older. Approval was based on Study INCB 18424-271 (NCT02953678), an open-label, single-arm, multicenter study of ruxolitinib that enrolled 49 patients with steroid-refractory acute GVHD Grades 2 to…

FDA approves alpelisib and ruxolitinib

• FLASCO
• May 28, 2019
• Drugs
• No Comments

On May 24, 2019, the Food and Drug Administration approved alpelisib (PIQRAY, Novartis Pharmaceuticals Corporation) in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen….

A first-line combination Rx for advanced RCC is here

• Amanda Bridges
• May 24, 2019
• Drugs
• No Comments

FDA approves avelumab plus axitinib for renal cell carcinoma

• FLASCO
• May 16, 2019
• Drugs
• No Comments

On May 14, 2019, the Food and Drug Administration approved avelumab (BAVENCIO®, EMD Serono, Inc.) in combination with axitinib for first-line treatment of patients with advanced renal cell carcinoma (RCC). Approval was based on JAVELIN Renal 101 (NCT02684006), a randomized, multicenter, open-label trial of avelumab plus axitinib in 886 patients with untreated advanced RCC regardless…

FDA approves venetoclax for CLL and SLL

• FLASCO
• May 16, 2019
• Drugs
• No Comments

On May 15, 2019, the Food and Drug Administration approved venetoclax (VENCLEXTA, AbbVie Inc. and Genentech Inc.) for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Approval was based on CLL14 (NCT02242942), a randomized (1:1), multicenter, open label, actively controlled trial of venetoclax in combination with obinutuzumab (VEN+G) versus obinutuzumab in…

FDA Approves ramucirumab for hepatocellular carcinoma

• FLASCO
• May 13, 2019
• Drugs
• No Comments

On May 10, 2019, the Food and Drug Administration approved ramucirumab (CYRAMZA®, Eli Lilly and Company) as a single agent for hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein (AFP) of ≥ 400 ng/mL and have been previously treated with sorafenib. Approval was based on REACH 2 (NCT02435433), a multinational, randomized, double-blind, placebo-controlled,…

BALVERSA™ (erdafitinib) Receives U.S. FDA Approval for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Carcinoma with Certain FGFR Genetic Alterations

• Katrina Williams
• May 13, 2019
• Drugs
• No Comments

Apr 12, 2019 United States — BALVERSA is the first FGFR kinase inhibitor to receive U.S. FDA approval — Simultaneous approval of companion diagnostic intended to identify a subset of patients most likely to benefit from BALVERSA, offering a personalized treatment approach HORSHAM, Pa., April 12, 2019  — The Janssen Pharmaceutical Companies of Johnson & Johnson announced…

FDA approves ado-trastuzumab emtansine for early breast cancer

• FLASCO
• May 6, 2019
• Drugs
• No Comments

On May 3, 2019, the Food and Drug Administration approved ado-trastuzumab emtansine (KADCYLA®, Genentech, Inc.) for the adjuvant treatment of patients with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Patients should be selected based on an FDA-approved companion diagnostic for ado-trastuzumab emtansine. FDA also approved both…

Merck is pleased to announce that KEYTRUDA, in combination with axitinib, has been approved by the FDA for the first-line treatment of patients with advanced renal cell carcinoma (RCC)

• FLASCO
• May 3, 2019
• Drugs
• No Comments

Merck is pleased to announce that KEYTRUDA, in combination with axitinib, has been approved by the FDA for the first-line treatment of patients with advanced renal cell carcinoma (RCC). PD-L1 diagnostic testing is not required prior to initiating treatment with KEYTRUDA in these patients FDA=Food and Drug Administration; PD-L1=programmed death ligand 1. Selected Safety Information…

KEYTRUDA(R) (pembrolizumab): Additional Indication

• Katrina Williams
• May 3, 2019
• Drugs
• No Comments

Merck is pleased to announce that KEYTRUDA, in combination with axitinib, has been approved by the FDA for the first-line treatment of patients with advanced renal cell carcinoma (RCC). PD-L1 diagnostic testing is not required prior to initiating treatment with KEYTRUDA in these patients FDA=Food and Drug Administration; PD-L1=programmed death ligand 1. Selected Safety Information…

FDA approves pembrolizumab plus axitinib for advanced renal cell carcinoma

• FLASCO
• April 22, 2019
• Drugs
• No Comments

On April 19, 2019, the Food and Drug Administration approved pembrolizumab (KEYTRUDA®, Merck & Co. Inc.) plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). Approval was based on KEYNOTE 426 (NCT02853331), a randomized, multicenter, open-label trial conducted in 861 patients who had not received systemic therapy for advanced RCC….

Announcing a New Genentech Therapy

• Katrina Williams
• April 17, 2019
• Drugs
• No Comments

Genentech is excited to share the news of a new FDA-approved therapy. Adjuvant Breast Cancer  HERCEPTIN HYLECTATM (trastuzumab and hyaluronidase-oysk) is indicated for adjuvant treatment of adults with HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer: As part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel With docetaxel and…

Genomic Health Introduces New Diagnostic Test Oncotype AR-V7

• Katrina Williams
• April 17, 2019
• Drugs
• No Comments

The Oncotype DX AR-V7 Nucleus Detect® Assay is the first and only nuclear-localized AR-V7 liquid biopsy blood test that can help guide treatment decisions for patients diagnosed with mCRPC who have received and failed an AR-targeted therapy such as XTANDI® (enzalutamide), ZYTIGA® (abiraterone), or ERLEADA™ (apalutamide). The Oncotype DX AR-V7 Nucleus Detect test can help…

FDA approves Genentech’s atezolizumab for extensive-stage small cell lung cancer

• FLASCO
• March 19, 2019
• Drugs
• No Comments

On March 18, 2019, the Food and Drug Administration approved atezolizumab (TECENTRIQ, Genentech Inc.) in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Approval was based on IMpower133 (NCT02763579), a randomized (1:1), multicenter, double-blind, placebo-controlled trial in 403 patients with ES-SCLC who received no…

U.S. FDA Approves Pfizer’s Oncology Biosimilar Trazimera™ (Trastuzumab-QYYP), A Biosimilar To Herceptin®

• FLASCO
• March 12, 2019
• Drugs
• No Comments

Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved TRAZIMERA™ (trastuzumab-qyyp), a biosimilar to Herceptin® (trastuzumab),1 for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.2 “This is an important milestone in the U.S. which both adds…

FDA approves Genentech’s atezolizumab for PD-L1 positive unresectable locally advanced or metastatic triple-negative breast cancer

• FLASCO
• March 11, 2019
• Drugs
• No Comments

On March 8, 2019, the Food and Drug Administration granted accelerated approval to atezolizumab (TECENTRIQ®, Genentech Inc.) in combination with paclitaxel protein-bound for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥ 1% of the tumor area),…

FDA approves Genentech’s trastuzumab and hyaluronidase-oysk injection

• FLASCO
• February 28, 2019
• Drugs
• No Comments

On February 28, 2019, the Food and Drug Administration approved trastuzumab and hyaluronidase-oysk injection,for subcutaneous use (Herceptin Hylecta, Genentech Inc.). Herceptin Hylecta is a combination of trastuzumab, a HER2/neu receptor antagonist, and hyaluronidase, an endoglycosidase, for the treatment of HER2‑overexpressing breast cancer.  Approval was based on two randomized trials, HannaH (NCT00950300) and SafeHER (NCT01566721). In…

FDA approves Cablivi® (caplacizumab-yhdp), the first Nanobody®-based medicine, for adults with acquired thrombotic thrombocytopenic purpura (aTTP)

• Katrina Williams
• February 26, 2019
• Drugs
• No Comments

– First medicine approved in the U.S. specifically for the treatment of aTTP, a rare blood-clotting disorder – Cablivi is the first U.S. approval for Sanofi’s new rare blood disorders franchise BRIDGEWATER, N.J., Feb. 6, 2019 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Cablivi® (caplacizumab-yhdp) in combination with plasma exchange and immunosuppression for the…

FDA approves Taiho Oncology’s Lonsurf for recurrent, metastatic gastric and gastroesophageal junction adenocarcinoma

• FLASCO
• February 26, 2019
• Drugs
• No Comments

On February 22, 2019, the Food and Drug Administration approved trifluridine/ tipiracil tablets (LONSURF, Taiho Pharmaceutical Co., Ltd.)—a fixed combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor—for adult patients with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a…

FDA approves Merck’s pembrolizumab for adjuvant treatment of melanoma

• FLASCO
• February 19, 2019
• Drugs
• No Comments

On February 15, 2019, the Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck) for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.  Approval was based on EORTC1325/KEYNOTE‑054 (NCT02362594), a randomized, double-blind, placebo-controlled, trial in 1019 patients with completely resected, stage IIIA (>1 mm lymph node metastasis), IIIB or IIIC…

Guardant360 Policy

• Amanda Bridges
• February 1, 2019
• Drugs
• No Comments

The FLASCO Clinical Practice leadership approved and signed a letter of support written to FL Blue for the Guardant360 Liquid Biopsy test in 2018. The FLASCO office was recently notified and we are now sharing the victory with you, “Florida Blue has adopted a positive medical policy for the Guardant360 Liquid Biopsy test. A very…

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.

• Katrina Williams
• January 22, 2019
• Drugs
• No Comments

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

• FLASCO
• January 15, 2019
• Drugs
• No Comments

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…