FLASCO Diamond Corporate Member, AstraZeneca, is pleased to inform you that the US Food and Drug Administration (FDA) granted full approval for TAGRISSO® (osimertinib) 80mg once-daily tablets, for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed…
The U.S. Food and Drug Administration today granted accelerated approval to Bavencio (avelumab) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who have not received prior chemotherapy. This is the first FDA-approved treatment for metastatic MCC, a rare, aggressive form of skin cancer….
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…
On March 13, 2017, the U.S. Food and Drug Administration approved ribociclib (KISQALI®, Novartis Pharmaceuticals Corp.), a cyclin-dependent kinase 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Approval was…
The U.S. Food and Drug Administration approved Xermelo (telotristat ethyl) tablets in combination with somatostatin analog (SSA) therapy for the treatment of adults with carcinoid syndrome diarrhea that SSA therapy alone has inadequately controlled. Carcinoid syndrome is a cluster of symptoms sometimes seen in people with carcinoid tumors. These tumors are rare, and often slow-growing….
On February 22, 2017, the U.S. Food and Drug Administration approved lenalidomide (Revlimid®, Celgene Corp.) as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant. In 2006, lenalidomide, an orally administered thalidomide analogue, received FDA approval for use with dexamethasone in patients with multiple myeloma who received at least one prior therapy….
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has approved Opdivoinjection, for intravenous use for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment…
–FDA approval of FoundationFocus CDxBRCA marks important progress towards Foundation Medicine’s development of a comprehensive universal companion diagnostic assay across multiple tumor types to advance precision medicine in oncology– Foundation Medicine, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved FoundationFocus™ CDxBRCA for use as a companion diagnostic to aid in identifying women with ovarian cancer…
The FDA has approved AeroForm, a balloon-like wireless tissue expander, for patients who choose to have reconstructive surgery following a mastectomy or for those with underdeveloped breasts and soft tissue deformities. Devices like AeroForm are utilized before breast reconstruction to stretch breast tissue and muscle to create space for the implant. The FDA approved…
On December 19, 2016, the U.S. Food and Drug Administration granted accelerated approval to rucaparib (RUBRACA™, Clovis Oncology Inc.) for treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies. In conjunction with the drug approval, FDA approved the FoundationFocus™ CDxBRCA test…
FDA Approves Genentech’s Avastin® (Bevacizumab) Plus Chemotherapy for a Specific Type of Advanced Ovarian Cancer Approval based on two large Phase III studies including GOG-0213 that showed a five month overall survival difference for women with platinum-sensitive recurrent ovarian cancer on Avastin plus chemotherapy compared to chemotherapy alone In the United States, Avastin is now…
On November 21, 2016, the U.S. Food and Drug Administration approved daratumumab (DARZALEX, Janssen Biotech, Inc.) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. Daratumumab was previously granted accelerated approval in November 2015 as monotherapy for patients…
On November 10, 2016, the U. S. Food and Drug Administration approved nivolumab (OPDIVO Injection, Bristol-Myers Squibb Company), for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy. Approval was based on data from an international, multi-center, open-label,…
Pembrolizumab (KEYTRUDA) On October 24, 2016, the U.S. Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co., Inc.) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test. This is the first FDA approval of a checkpoint inhibitor for first-line treatment…
– ONIVYDE® in combination with fluorouracil (5-FU) and leucovorin establishes a new standard of care for patients with metastatic pancreatic cancer who have progressed on gemcitabine-based therapy – Disease control achieved in twice as many patients treated with ONIVYDE in combination with 5-FU and leucovorin (52%) compared to 5-FU and leucovorin alone (24%) CAMBRIDGE,…
On October 18, 2016, the U.S. Food and Drug Administration modified the indication for erlotinib (TARCEVA, Astellas Pharm Global Development Inc.) for treatment of non-small cell lung cancer (NSCLC) to limit use to patients whose tumors have specific epidermal growth factor receptor (EGFR) mutations. The labeling change applies to patients with NSCLC receiving maintenance or…
On October 18, 2016, FDA approved atezolizumab (TECENTRIQ, Genentech Oncology) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose disease progressed during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving atezolizumab. Atezolizumab is a programmed…
— LARTRUVO, in combination with doxorubicin, is the first FDA-approved front-line therapy for soft tissue sarcoma in four decades — The approval was based on results from the positive Phase 2 JGDG trial — LARTRUVO received the FDA’s Breakthrough Therapy Designation and was approved under the Agency’s Accelerated Approval program Eli Lilly and Company (NYSE:…
NDC NUMBER CHANGE Former GlaxoSmithKline (fGSK) Products EFFECTIVE IMMEDIATELY, please note that the current NDC numbers are being replaced by the NEW NDC NUMBERS referenced below: Product Name: ARRANON® (nelarabine) Old NDC #0007-4401-06 New NDC # 0078-0683-06 Package Size: 6 vials x 50 mL Package Strength: 250 mg/50 mL Direct Purchasers: Effective immediately, please use the New…
The following is important information regarding a unique C-code that was recently assigned to TECENTRIQ™ (atezolizumab) by the Centers for Medicare & Medicaid Services (CMS). The C-code for TECENTRIQ is C9483 (Injection, atezolizumab, 10 mg). The unique C-code goes into effect on October 1, 2016. Payers may require its use until a permanent J-code is…
AstraZeneca announced that the US Food and Drug Administration (FDA) has approved a blood-based companion diagnostic for TAGRISSO® (osimertinib). The companion diagnostic for TAGRISSO is the only FDA-approved and clinically validated companion diagnostic test that uses either tissue or a blood sample to confirm the presence of a T790M mutation in patients with metastatic epidermal…
On September 13, 2016, the U.S. Food and Drug Administration modified the dosage regimen for nivolumab (Opdivo, Bristol-Myers Squibb Co.) for the currently approved indications for renal cell carcinoma, metastatic melanoma, and non-small cell lung cancer. The currently approved recommended dosage regimens were modified to 240 mg intravenously (IV) every two weeks. The approval modifies the…
Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO®(blinatumomab) to include new data supporting the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval, and continued approval may be…
Genmab A/S announced that the FDA has approved a supplemental Biologics License Application (sBLA) for the use of ofatumumab (Arzerra®) in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL). Read corporate press release »
The FDA announced efforts to help mitigate the shortage of Bleomycin Sulfate for Injection. The agency will be coordinating with Amneal Bioscience to import its Bleomycin Sulfate Powder for Injection, which contains the same active ingredients as the FDA-approved Bleomycin Sulfate for Injection. In April, the FDA posted information on its website regarding…
Amerigen Pharmaceuticals Limited (“Amerigen”) announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company’s Abbreviated New Drug Application (ANDA) for a generic version of Temodar® (temozolomide capsules 5, 20, 100, 140, 180 and 250mg). The product has been launched and is manufactured by Stason Pharmaceuticals, Inc. (“Stason”) in Irvine,…
TYKERB®(lapatinib)NDC NUMBER CHANGE Former GlaxoSmithKline (fGSK) Products EFFECTIVE IMMEDIATELY, please note that the current NDC numbers are being replaced by the NEW NDC NUMBERS referenced in Table A below: Table A: Product Name Old NDC # New NDC # Package Size Package Strength TYKERB® (lapatinib) 0173-0752-00 0078-0671-19 150 tablets 250mg Direct Purchasers:Effective immediately,…
FDA granted accelerated approval to pembrolizumab (KEYTRUDA injection, Merck Sharp & Dohme Corp.) for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. Click here for Merck’s announcement For More FDA Information Click Here Medication Guide Prescribing Information…
CVS Health Corp. will add 35 products to its lists of excluded drugs in 2017 and no longer cover some treatments for cancer and diabetes, in an aggressive move to favor lower-priced treatments and target what the company called “hyperinflation” of some other products. The drug benefit manager will remove coverage for Novartis AG’s leukemia…
Foundation Medicine has launched a new assay, FoundationACT (Assay for Circulating Tumor DNA), a rigorously validated and highly accurate blood-based circulating tumor DNA (ctDNA) assay that provides patients and oncologists with a new option for comprehensive genomic profiling when a tissue biopsy is not feasible or when tissue is not available. By analyzing cell-free…
Molecular Test to Guide CML Therapy OK’d FDA clears first quantitative nucleic acid assay for BCR-ABL A molecular diagnostic for measuring BCR-ABL levels in patients with chronic myeloid leukemia (CML) was cleared for marketing Friday, the FDA announced. It’s the first quantitative nucleic acid assay for this purpose to be approved in the U.S., the…
Merck is pleased to announce that EMEND for oral suspension is now available. (Click the below image to enlarge) EMEND® is a substance P/neurokinin 1 (NK1) receptor antagonist. EMEND for oral suspension is indicated in combination with other antiemetic agents, in patients 6 months of age and older for prevention of: acute and delayed nausea and…
Heron Therapeutics Announces U.S. FDA Approval of SUSTOL® (granisetron) Extended-Release Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting SUSTOL is the first extended-release 5-HT3 receptor antagonist approved for the prevention of acute and delayed nausea and vomiting associated with both moderately emetogenic chemotherapy and anthracycline and cyclophosphamide combination chemotherapy regimens A standard of care…
On August 5, 2016, the U. S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA injection, Merck Sharp & Dohme Corp.) for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. The approval was based on demonstration of a…
Insys Therapeutics, Inc. (“Insys” or “the Company”) (INSY) today announced that the U.S. Food and Drug Administration (FDA) has approved Insys’ dronabinol oral solution, SyndrosTM, an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol (“THC”). Syndros is approved for use in treating anorexia associated with weight loss in patients…
NATIONAL COMPREHENSIVE CANCER NETWORK®(NCCN®) STATUS1 NCCN CLINICAL PRACTICE GUIDELINES IN ONCOLOGY (NCCN GUIDELINES®) CATEGORY DESIGNATION1 Rituximab (RITUXAN®) is included in the NCCN Guidelines® with a category 1 designation for first-line maintenance therapy (one 375 mg/m2 dose every 2 months for 2 years) in follicular lymphoma patients initially presenting with high tumor burden1 Note: Category 1 designation is given…
As you likely know, CMS has a National Coverage Determination policy outlining when to bill under Medicare Part B vs Part D when using oral anti-emetic therapies. Under these policies, providers should bill under Part B only when specific criteria are met, including that the oral anti-emetics are used “as full replacement for the anti-emetic…
The U.S. Food and Drug Administration today approved Axumin, a radioactive diagnostic agent for injection. Axumin is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated prostate specific antigen (PSA) levels following prior treatment. Prostate cancer is the second leading cause of death from cancer in U.S….
The U.S. Food and Drug Administration today approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate injection, a radioactive diagnostic agent for positron emission tomography (PET) imaging. This radioactive probe will help locate tumors in adult and pediatric patients with the rare condition, somatostatin receptor positive neuroendocrine tumors (NETs). NETs are…
On June 1, 2016, the U. S. Food and Drug Administration approved cobas EGFR Mutation Test v2 (Roche Molecular Systems, Inc.) using plasma specimens as a companion diagnostic test for the detection of exon 19 deletions or exon 21 (L858R) substitution mutations in the epidermal growth factor recptor (EGFR) gene to identify patients with metastatic…
U. S. Food and Drug Administration gave accelerated approval to atezolizumab injection (Tecentriq, Genentech, Inc.) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Atezolizumab is a programmed…
Click Here to Read the Corporate Press Release On May 17, 2016, the U. S. Food and Drug Administration granted accelerated approval to nivolumab (Opdivo, marketed by Bristol-Myers Squibb) for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin…
Eisai Inc. announced that the U.S. Food and Drug Administration (FDA) approved LENVIMA® (lenvatinib), the company’s multiple receptor tyrosine kinase inhibitor, in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (aRCC) who were previously treated with an anti-angiogenic therapy. This approval was based on the impressive results of the registration study (Study 205),…
Source: Reuters An experimental AstraZeneca drug that failed last year as a treatment for a rare cancer of the eye has been awarded special “orphan” status in the United States for a type of thyroid cancer. The British drugmaker, which is relying on cancer treatments to revive its fortunes following a wave of patent expiries,…
TOLMAR Pharmaceuticals has secured from FDA for a label update for ELIGARD, indicated for the palliative treatment of advanced prostate cancer. Stability studies demonstrated that, prior to mixing, ELIGARD may be stored at room temperature (59 – 86° F) for up to 8 weeks following removal from refrigeration. ELIGARD is the only LHRH (luteinizing hormone…
Source: Business Wire Laboratory Corporation of America® Holdings (LabCorp®) today announced the launch of Epi proColon®, a blood-based test for colorectal cancer screening that was approved on April 13, 2016 for clinical use by the U.S. Food and Drug Administration (FDA). Epi proColon® is the first FDA-approved DNA based blood test for colorectal cancer. The…
NanoString Technologies announced today that health insurer Aetna has added the Prosigna breast cancer test to its Tumor Markers Clinical Policy Bulletin, opening the door for test coverage. Prosigna is an in vitro diagnostic test that uses the PAM50 gene expression signature to assess prognosis and risk of disease recurrence for patients with specific types…
U.S. FDA Expands IMBRUVICA (Ibrutinib) Label To Include Overall Survival Data In Previously Untreated Chronic Lymphocytic Leukemia (CLL) And New Indication For Small Lymphocytic Lymphoma (SLL) Patients U.S. Food and Drug Administration (FDA) updated the IMBRUVICA® (ibrutinib) Prescribing Information (PI) to include new data from two Phase 3 trials supporting its expanded use in patients with…
Foundation Medicine, Inc. announced the launch of FoundationACT (Assay for Circulating Tumor DNA), an analytically validated and accurate blood-based circulating tumor DNA (ctDNA) assay that provides patients and oncologists with a new option for comprehensive genomic profiling when a tissue biopsy is not feasible or when tissue is not available. By analyzing circulating tumor DNA isolated…
Genentech BioOncology® Access Solutions and Patient Partners™ Genentech BioOncology Access Solutions provides reliable, effective access and reimbursement services to assist your patients and practice. We can help address the needs of each patient’s coverage scenario. Available assistance for your eligible patients*: Patient situation Patient assistance option Insurance status of potentially eligible patients † Genentech does…
On April 25, 2016, the U. S. Food and Drug Administration approved cabozantinib (CABOMETYX, Exelixis, Inc.) for the treatment of advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy. The approval was based on a randomized study in which patients with advanced renal cell carcinoma who had received prior anti-angiogenic therapy received…
Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Gilotrif® (afatinib) tablets for the treatment of patients with advanced squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy. read article »
The U. S. Food and Drug Administration approved Defitelio (defibrotide sodium, Jazz Pharmaceuticals, Inc.) for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstructive syndrome, with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT). More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm493278.htm
Merrimack Pharmaceuticals has announced that the Centers for Medicare & Medicaid Services (CMS) issued a C-code forOnivyde™ (irinotecan liposome injection), effective April 1, 2016: C9474, Injection, irinotecan liposome, 1 mg. Onivyde (irinotecan liposome injection) is indicated, in combination with fluorouracil (5-FU) and leucovorin (LV), for the treatment of patients with metastatic adenocarcinoma of the pancreas…
Abbott announced today that the US Food and Drug Administration has granted premarket approved for the company’s Vysis CLL FISH Probe Kit as a companion diagnostic for AbbVie and Genentech’s newly approved chronic lymphocytic leukemia (CLL) drug Venclexta (venetoclax). Venclexta, a BCL-2 inhibitor, received FDA clearance this week for the treatment of CLL patients with…
The US Food and Drug Administration (FDA) has indicated that there are no substantive deficiencies in Heron Therapeutics’ new drug application (NDA) for Sustol (granisetron) Injection (extended release) to treat acute and delayed chemotherapy-induced nausea and vomiting (CINV). Labeling negotiations are now underway. The FDA extended the original action date of 17 January twice to…
Drug Warning: Zydelig from flasco_org
On April 11, 2016, the U. S. Food and Drug Administration approved venetoclax (VENCLEXTA tablets, marketed by AbbVie, Inc. and Genentech USA, Inc.) for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. The approval was based on the…
On March 11, 2016, the U. S. Food and Drug Administration approved crizotinib capsules (Xalkori, Pfizer, Inc.) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. Crizotinib was first approved in 2011 for the treatment of patients whose tumors are anaplastic lymphoma kinase (ALK)-positive. The current approval was based…
The U.S. Food and Drug Administration today approved Idelvion, Coagulation Factor IX (Recombinant), Albumin Fusion Protein, for use in children and adults with Hemophilia B. Idelvion is the first coagulation factor-albumin fusion protein product to be approved, and the second Factor IX fusion protein product approved in the U.S. that is modified to last longer…
APPROVAL BASED ON DATA FROM THE PHASE 3 RESONATE™-2 TRIAL SHOWING AN 84% REDUCTION IN THE RISK OF PROGRESSION OR DEATH WITH IMBRUVICA COMPARED TO CHLORAMBUCIL FIRST FDA-APPROVED CHEMOTHERAPY-FREE TREATMENT OPTION FOR FIRST-LINE CLL PATIENTS THIS IS THE 5TH TREATMENT INDICATION FOR IMBRUVICA AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced the U.S. Food…
FDA Grants Spectrum Pharmaceuticals Approval of EVOMELA™ (melphalan) for Injection EVOMELA Received FDA Approval for Two Indications: High-Dose Conditioning Treatment for Multiple Myeloma (MM) Patients Undergoing Autologous Stem Cell Transplantation (ASCT) Palliative Treatment of Patients with MM Who Cannot Take Oral Therapy EVOMELA Admixture Solution is Stable for 4 Hours at Room Temperature in Addition…
On February 19, 2016, the U. S. Food and Drug Administration approved palbociclib (IBRANCE Capsules, Pfizer, Inc.) in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. In February 2015, FDA granted accelerated approval…
As a healthcare provider, you play an essential role in helping patients taking COTELLIC + ZELBORAF manage treatment. Genentech has created this Adverse Drug Reactions Guide as a quick reference on monitoring and managing possible serious or common ADRs. This guide offers information on the signs and symptoms of certain possible ADRs experienced by patients…
Approval expands use and offers additional option for women with HR+, HER2- metastatic breast cancer AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved a new indication expanding the use of FASLODEX® (fulvestrant) to include use in combination with palbociclib. The combination use is for the treatment of women with hormone…
On February 26, 2016, the U. S. Food and Drug Administration approved everolimus (Afinitor , Novartis) for the treatment of adult patients with progressive, well-differentiated non-functional, neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease. Today’s approval was based on demonstration of improvement in progression-free survival (PFS) in…
FDA Approves New Indication for Merck’s EMEND for Injection Announcement Letter Press Release Prescribing Information Patient Product Information Merck announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for single-dose EMEND® (fosaprepitant dimeglumine) for injection, Merck’s substance P/neurokinin-1 (NK1) receptor antagonist, in combination with other antiemetic medicines,…
Eisai is pleased to announce that HALAVEN® (eribulin mesylate) Injection (0.5 mg per mL) is now approved by the US Food and Drug Administration (FDA) for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.1 HALAVEN has been approved for the treatment of third-line metastatic breast cancer since…
The U.S. Food and Drug Administration today approved Eisai’s Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug. “Halaven is…
Dako, an Agilent Technologies Company, Announces Expanded FDA Approval of Complementary Diagnostic Test to Include Melanoma Dako, an Agilent Technologies company and a worldwide provider of cancer diagnostics, today announced that the U.S. Food and Drug Administration (FDA) has approved the expansion of the intended use of Dako PD-L1 IHC 28-8 pharmDx to include patients…
Opdivo + Yervoy Regimen now indicated for unresectable or metastatic melanoma patients, regardless of BRAF mutational status, based on accelerated approval1 Demonstrated significantly superior progression-free survival vs. Yervoy alone in CheckMate -067 with the first and only FDA-approved combination of immune checkpoint inhibitors1,2 FDA also expands use of Opdivo as single-agent to include previously untreated BRAF mutation-positive advanced melanoma…
AbbVie and Roche’s investigational BCL-2 inhibitor venetoclax was granted priority review by the FDA for the treatment of chronic lymphocytic leukaemia (CLL) in patients, including those with p17 deletion, who received at least one prior therapy, Roche announced Tuesday. Roche chief medical officer Sandra Horning said “we look forward to working with AbbVie and health…
On January 19, 2016, the U.S. Food and Drug Administration approved ofatumumab (Arzerra Injection, Novartis Pharmaceuticals Corporation) for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). Ofatumumab was previously approved for the treatment of previously untreated patients…
Originally published on CNN, here. Pivotal Head-To-Head ENDEAVOR Study Shows Kyprolis and Dexamethasone Doubled Progression-Free Survival Versus Velcade® (Bortezomib) and Dexamethasone Kyprolis Label Expansion Represents Critical Advancement for Patients With Relapsed or Refractory Multiple Myeloma, Offering New Option For Backbone Therapy Approval Expands Kyprolis Indication and Converts Monotherapy Indication to Full Approval. THOUSAND OAKS, Calif., Jan. 21,…
FDA Expands Label For Pembrolizumab (Keytruda® Injection, Merck Sharp & Dohme Corp) Corporate Press Release Prescribing Information Medication Guide On December 18, 2015, the U. S. Food and Drug Administration (FDA) expanded the label to include the approval of pembrolizumab (Keytruda® Injection, Merck Sharp & Dohme Corp.) for the treatment of patients with unresectable or…
J Code for KEYTRUDA® (pembrolizumab) Available KEYTRUDA has been assigned a permanent HCPCS* code, effective January 1, 2016.1 HCPCS CODE DESCRIPTOR J9271 Injection, pembrolizumab, 1 mg For dates of service prior to January 1, 2016, use the appropriate unspecified HCPCS code to bill for KEYTRUDA. If you have questions about KEYTRUDA, please contact your…
The U.S. Food and Drug Administration today approved Vistogard (uridine triacetate) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments. “Treating cancer requires not only selecting which drug may…
Click here to read corporate press release The U.S. Food and Drug Administration today approved Alecensa (alectinib) to treat people with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate treatment with, another therapy called Xalkori (crizotinib). Lung cancer is the leading cause of cancer death…
The U.S. Food and Drug Administration today approved Bridion (sugammadex) injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used during certain types of surgery in adults. Rocuronium bromide and vecuronium bromide are neuromuscular blocking drugs that cause temporary paralysis by interfering with the transmission of nerve…
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) today announce that the U.S. Food and Drug Administration (FDA) has approved BENDEKA™, (bendamustine hydrochloride) injection, a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine. BENDEKA is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment…
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