The U.S. Food and Drug Administration approved Vonvendi, von Willebrand factor (Recombinant), for use in adults 18 years of age and older who have von Willebrand disease (VWD). Vonvendi is the first FDA-approved recombinant von Willebrand factor, and is approved for the on-demand (as needed) treatment and control of bleeding episodes in adults diagnosed with…
U.S. Food and Drug Administration cleared for marketing in the United States the first cooling cap to reduce hair loss (alopecia) in female breast cancer patients undergoing chemotherapy. Hair loss is a common side effect of certain types of chemotherapy, commonly associated with the treatment of breast cancer. Hair may fall out entirely, gradually, in…
Announcing the assignment of a product-specific Healthcare Common Procedure Coding System (HCPCS) code for CYRAMZA® (ramucirumab) for injection. The new code, J9308, is defined as Injection, ramucirumab, 5 mg. This code is effective January 1, 2016. Trade Name HCPCS Code1 Strength NDC* CYRAMZA J9308 Injection, ramucirumab, 5 mg 100 mg/10 mL (10 mg/mL) 500…
Click here to read corporate press release U.S. Food and Drug Administration granted approval for Empliciti (elotuzumab) in combination with two other therapies to treat people with multiple myeloma who have received one to three prior medications. Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells (a type of white…
Click here for corporate release The U.S. Food and Drug Administration granted approval for Empliciti (elotuzumab) in combination with two other therapies to treat people with multiple myeloma who have received one to three prior medications. Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells (a type of white…
FDA approves Lilly’s Portrazza to treat advanced squamous non-small cell lung cancer The U.S. Food and Drug Administration today approved Portrazza (necitumumab) in combination with two forms of chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer. Lung…
On November 23, 2015, the U. S. Food and Drug Administration approved nivolumab (Opdivo Injection, Bristol-Myers Squibb Company) 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 cancer who had received prior anti-angiogenic…
On November 20, 2015, the U.S. Food and Drug Administration approved ixazomib (NINLARO, Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Ixazomib is the first approved oral proteasome inhibitor….
Novartis receives FDA regular approval for Tafinlar® + Mekinist® to treat aggressive form of melanoma based on long-term survival data The U. S. Food and Drug Administration granted accelerated approval to trametinib and dabrafenib for use in combination in the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K…
On November 13, 2015, the U. S. Food and Drug Administration granted accelerated approval to osimertinib (TAGRISSO) once daily tablets, AstraZeneca Pharmaceuticals LP, 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, who have progressed on or after EGFR tyrosine…
On November 16, 2015, the U.S. Food and Drug Administration granted accelerated approval to daratumumab injection (DARZALEX, Janssen Biotech, Inc.), administered as a single agent for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are…
FDA Approves Gilead’s Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection The U.S. Food and Drug Administration approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of…
FDA Approves Genentech’s Cotellic™ (Cobimetinib) in Combination With Zelboraf® (Vemurafenib) in Advanced Melanoma Click here to read corporate press release The U.S. Food and Drug Administration approved Cotellic (cobimetinib) to be used in combination with vemurafenib to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery,…
U.S. Food and Drug Administration expanded the approved use of Yervoy (ipilimumab) to include a new use as adjuvant therapy for patients with stage III melanoma, to lower the risk that the melanoma will return following surgery. Melanoma, the most aggressive type of skin cancer, is the leading cause of death from skin cancer. Melanoma…
The U.S. Food and Drug Administration today approved Imlygic (talimogene laherparepvec), the first FDA-approved oncolytic virus therapy, for the treatment of melanoma lesions in the skin and lymph nodes. “Melanoma is a serious disease that can advance and spread to other parts of the body, where it becomes difficult to treat,” said Karen Midthun, M.D.,…
Yondelis (trabectedin) Janssen The U.S. Food and Drug Administration today approved Yondelis (trabectedin), a chemotherapy, for the treatment of specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who previously received chemotherapy that contained anthracycline. According to…
The U.S. Food and Drug Administration today approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with advanced (metastatic) pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy. According to the National Cancer Institute, there will be 48,960 new cases of pancreatic cancer diagnosed in the U.S. in 2015,…
Rosetta Genomics Ltd. a leading developer and provider of microRNA-based and other molecular diagnostics, announces the launch of a molecular test for BRAF mutation analysis to help personalize therapy for melanoma and colon cancer patients. This newest assay will complement its broad offerings so that oncologists can optimize treatment decisions for their cancer patients. Rosetta…
On October 9, 2015, the FDA approved Opdivo (nivolumab) to treat patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy. “The U.S. Food and Drug Administration today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy….
KEYTRUDA is indicated 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 with disease progression on or after 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 KEYTRUDA. This…
FDA approved an expanded indication for the Optune device to treat patients with newly-diagnosed glioblastoma multiforme (GBM), an aggressive form of brain cancer. It is given along with the chemotherapy drug temozolomide (TMZ) following standard treatments that include surgery, chemotherapy, and radiation therapy. [su_button url=”http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTUxMDA3LjQ5OTcwNzExJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE1MTAwNy40OTk3MDcxMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3MjAxMTM4JmVtYWlsaWQ9RG9yb3RoeS5HcmVlbkBmbGFzY28ub3JnJnVzZXJpZD1Eb3JvdGh5LkdyZWVuQGZsYXNjby5vcmcmZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg==&&&107&&&http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm465744.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery” target=”blank” style=”flat” background=”#ff002d” color=”#fafafa” size=”5″ center=”yes” icon=”icon: hand-o-right” icon_color=”#ffffff” text_shadow=”0px…
Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab), for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. Read Corporate Press Release FDA Information: U. S. Food and Drug Administration granted accelerated approval to nivolumab (Opdivo Injection, Bristol-Myers Squibb Company) in…
(BUSINESS WIRE)–Merck and Pfizer announced that the US Food and Drug Administration (FDA) has granted orphan drug designation for the investigational cancer immunotherapy avelumab* for the treatment of Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer.1,2 Each year, there are approximately 1,500 new cases of MCC diagnosed in the US.3 “We…
Moffitt Cancer Center and Bristol-Myers Squibb Enter Into a Collaboration Agreement as Part of U.S. Immuno-Oncology Rare Population Malignancy Program NEW YORK & TAMPA, Fla., Sep 25, 2015 (BUSINESS WIRE) — Bristol-Myers Squibb Company and Moffitt Cancer Center today announced that they have entered into a collaboration agreement as part of Bristol-Myers Squibb’s Immuno-Oncology…
On September 22, 2015, the U.S. Food and Drug Administration approved LONSURF® (trifluridine and tipiracil) tablets. LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF…
Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial The Lancet Oncology has recently published the overall survival (OS) data from a head-to-head Phase III clinical trial. The study evaluated a lung cancer treatment as a potential option for patients with…
FDA Approves New Oral Medication to Treat Patients with Advanced Colorectal Cancer The U.S. Food and Drug Administration today approved Taiho Oncology’s Lonsurf (a pill that combines two drugs, trifluridine and tipiracil) for patients with an advanced form of colorectal cancer who are no longer responding to other therapies. “The past decade has brought a new…
ADCETRIS® (brentuximab vedotin) NEW INDICATION Dear Healthcare Professional: Seattle Genetics is pleased to announce FDA approval for use of ADCETRIS® (brentuximab vedotin) as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation treatment for patients with classical Hodgkin lymphoma (HL) at high risk of relapse or progression. The FDA decision was based on the positive results…
FDA Approves Varubi (rolapitant) Treatment for Nausea and Vomiting from Chemotherapy The U.S. Food and Drug Administration approved Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Varubi is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing (emetogenic…
FDA approves Promacta (eltrombopag) to Treat Low Blood Platelet Count in Pediatric Patients The U.S. Food and Drug Administration today approved Promacta (eltrombopag) to treat low blood platelet count in pediatric patients – ages one year and older – with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP). Promacta can be used in…
[su_list icon=”icon: check” icon_color=”#1243fe”] FDA Approval Based on the Phase 3 AETHERA Clinical Trial Results- AETHERA Trial Also Converts Prior Accelerated Approval to Regular Approval in Treatment of Classical Hodgkin Lymphoma Patients who Fail Autologous Hematopoietic Transplantation or who Fail at Least Two Prior Multi-Agent Chemotherapy Regimens and are Not Autologous Hematopoietic Transplantation Candidates Label…
Myriad’s myPlan® Lung Cancer Myriad’s myPlan® Lung Cancer is a new RNA 46-gene expression signature based on cell cycle progression (CCP) genes —the genes that regulate cell division. myPlan Lung Cancer measures the expression levels of specific genes in combination with pathological stage to predict the 5-year risk of lung cancer death in patients with…
AKYNZEO® (netupitant/palonosetron) Florida Society of Clinical Oncology (FLASCO) News Flash In 2014, Eisai launched AKYNZEO (netupitant/palonosetron), a dual-action, single-dose oral antiemetic for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO is an oral fixed combination of…
Sonidegib (Odomzo Capsules) Approved by FDA (Novartis Pharmaceuticals Corporation) FDA approved sonidegib (Odomzo Capsules, Novartis Pharmaceuticals Corporation) for the treatment of patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. July 24, 2015. More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm455865.htm
Carfilzomib (Kyprolis) Approved by FDA (Onyx Pharmaceuticals, Inc., an Amgen Subsidiary) On July 24, 2015, the U.S. Food and Drug Administration approved a new indication for Kyprolis® (carfilzomib) for injection.1 KYPROLIS can now be used in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to…
Afatinib versus Erlotinib as Second-line Treatment Phase III Clinical Trial Update Boehringer Ingelheim Pharmaceuticals, Inc. would like to share the overall survival (OS) data from a head-to-head Phase III clinical trial that was recently published in The Lancet Oncology. The study evaluated the company’s lung cancer treatment as a potential option for patients with advanced…
In a Pivotal Study, Genentech’s Investigational Immunotherapy Atezolizumab Shrank Tumors in People With a Specific Type of Bladder Cancer Results showed that high levels of PD-L1 expression were associated with greater responses to atezolizumab Genentech will discuss results with the U.S. Food and Drug Administration (FDA) as part of atezolizumab’s Breakthrough Therapy Designation in bladder…
AstraZeneca recently received approval from the Food and Drug Administration for IRESSA® (gefitinib) as a first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. IRESSA is approved in 91 countries…
POMALYST (POMALIDOMIDE) LABEL UPDATE NOW AVAILABLE Celgene Corporation releases new phase 3 clinical trail information for Pomalyst. POMALYST (pomalidomide) + low-dose dexamethasone(dex) delivered significantly longer progression-free survival (PFS) vs high-dose dex in a phase 3 clinical trial. Pomalyst is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received…
AMGEN DISTRIBUTES IMPORTANT SAFETY UPDATES ON PROLIA® The FDA has required Amgen to distribute a safety update on Prolia® (denosumab) to professional societies as part of its REMS (Risk Evaluation and Mitigation Strategy) program. Prolia® is a RANK ligand (RANKL) inhibitor used to treat osteoporosis in postmenopausal women who have high risk of bone fracture….
NEW TEST: GENESTRAT (BIODESIX) Biodesix is pleased to announce the launch of GeneStrat, a liquid biopsy mutation test for genotyping tumors of NSCLC patients, is an exciting milestone for Biodesix. The combined diagnostic power of GeneStrat and VeriStrat will continue to help assist physicians in treating their patients by offering more information in a timely…
HCPCS C-CODE FOR BLINCYTO™ Onyx Pharmaceuticals, an Amgen subsidiary, announced the assignment of HCPCS C-code for BLINCYTO™ (blinatumomab) for Injection for intravenous use1. The Centers for Medicare and Medicaid Services (CMS) assigned a unique C-code for BLINCYTO which became effective on April 1, 2015. HCPCS Code BLINCYTO Long Descriptor Strength Effective Date C9449 Injection, blinatumomab,…
GAZYVA® – NCCN GUIDELINES® CATEGORY 1 DESIGNATION Obinutuzumab (GAZYVA®) + chlorambucil is included in the NCCN Guidelines® with a category 1 designation for first-line therapy in the following CLL patients without del(17p)*: – Age ≥70 years – Younger patients (age <70 years) with significant comorbidities – Frail patients with significant comorbidities Note: Category 1…
ROCHE RECEIVES FDA APPROVAL FOR COBAS® KRAS MUTATION TEST Roche announced that the U.S. Food and Drug Administration (FDA) has approved the cobas KRAS Mutation Test for diagnostic use. The real-time polymerase chain reaction (PCR) test is designed to identify KRAS mutations in tumor samples from patients with metastatic colorectal cancer and aid clinicians in…
FLUOROURACIL INJECTION USP (ADRUCIL) 5 G/100 ML (50 MG/ML) Teva Parenteral Medicines has issued a voluntary recall of eight lots of fluorouracil injection USP (Adrucil) 5 g/100 mL (50 mg/mL). The reason cited is the potential presence of particulate matter, namely, aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals. Individual 5…
OPDIVO NCCN GUIDELINES UPDATE Five days after the approval of OPDIVO for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, the National Comprehensive Cancer Network® (NCCN®) and their expert panel have made an interim update to the NCCN Guidelines® to include nivolumab (OPDIVO) as…
CMS Issued Guidance on Biosimilars Please review CMS Coverage of Biosimilars for more information. See new codes below: HCPCS Code Short Description Long Description Action Coverage Pricing Effective Date Q5101 Inj filgrastim g-csf biosim Injection, Filgrastim (G-CSF), Biosimilar, 1 microgram Add D 51 7/1/2015 Q9976 Inj Ferric Pyrophosphate Cit Injection, Ferric Pyrophosphate Citrate Solution,…
Ramucirumab mCRC On April 24, 2015, the U. S. Food and Drug Administration approved ramucirumab (CYRAMZA®, Eli Lilly and Company) for use in combination with FOLFIRI for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed on a first line bevacizumab-, oxaliplatin- and fluoropyrimidine-containing regimen. Ramucirumab is a recombinant human monoclonal…
VeriStrat® Lung Cancer Journal: VeriStrat Proteomic Test Improves Overall Survival and Decreases Medical Costs for Patients with Advanced NSCLC BOULDER, Colo.—March 24, 2015— Biodesix, Inc. today announced the publication in the journal Lung Cancer of a pivotal paper demonstrating the economic implications to the US healthcare system of using VeriStrat® in guiding treatment of…
FDA Approved Dinutuximab On March 10, 2015, the U. S. Food and Drug Administration approved dinutuximab (Unituxin, United Therapeutics Corporation), in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. Dinutuximab…
FDA Approves New Antifungal Drug Cresemba The FDA has approved Cresemba (isavuconazonium sulfate), a new antifungal drug product used to treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections. Cresemba is marketed by Astellas Pharma US, Inc., based in Northbrook, Illinois. Aspergillosis is a fungal infection caused by Aspergillus species, and mucormycosis…
Zarxio (filgrastim-sndz) The FDA approved filgrastim-sndz (ZARXIO Injection, Sandoz Inc.), as a biosimilar to US-licensed Neupogen for the five indications for which US-licensed Neupogen is approved. The formulation of ZARXIO differs from that of US-licensed Neupogen in one inactive component. Sandoz, a subsidiary of Novartis, is the first company to get approval for a biosimilar,…
Opdivo (nivolumab) The U.S. Food and Drug Administration today expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Lung cancer is the leading cause of cancer death in the United States, with an estimated 224,210 new diagnoses and…
ERWINAZE® (asparaginase Erwinia chrysanthemi) ERWINAZE® (asparaginase Erwinia chrysanthemi) is now FDA-approved to be administered intravenously (IV) in addition to the originally approved intramuscular (IM) route of administration. ERWINAZE for intramuscular injection (IM) or intravenous infusion (IV), 10,000 International Units/vial is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with…
Panobinostat (FARYDAK) Full prescribing information is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205353s000lbl.pdf FARYDAK® (panobinostat) capsules On February 23, 2015, the U.S. Food and Drug Administration (FDA) granted accelerated approval to panobinostat (FARYDAK capsules, Novartis Pharmaceuticals) in combination with bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior…
Revlimid The U.S. Food and Drug Administration has expanded the authorized use of Celgene Corp’s cancer drug Revlimid to include newly diagnosed patients with multiple myeloma. Previously the drug was only approved for patients who had received at least one previous therapy. Physicians in the United States have long been prescribing Revlimid for new patients…
Lenvima (lenvatinib) The U.S. Food and Drug Administration granted approval to Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease). Please see full Prescribing Information.
Metastatic NSCLC: 3 positive endpoints for 1L therapy Read More please click here
FDA Approves Palbociclib for Metastatic Breast Cancer The U. S. Food and Drug Administration granted accelerated approval to palbociclib (IBRANCE®, Pfizer, Inc.) for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast for their metastatic disease. Read more
Provenge NCCN recently updated their Prostate Cancer treatment guidelines based on guidance from a panel of academic Oncologists and Urologists and patient advocacy leaders from around the country. The updated NCCN guidelines elevate PROVENGE to a more prominent position, recommending its use as the first treatment with an overall survival advantage for men with asymptomatic…
Trastuzumab Emtansine (T-DM1)* ASCO® Clinical Oncology Practice Guidelines recommend trastuzumab emtansine (T-DM1)* as second-line therapy for advanced HER2+ breast cancer1,2. For complete information, please click here.
KEYTRUDA Will Now Be Supplied as a 100 mg/4 mL (25 mg/mL) Solution in a Single-Use Vial Merck is pleased to announce the availability of a liquid formulation of KEYTRUDA. Merck expects to make this product available on or after February 16, 2015. Check with your authorized distributor for details. This 100-mg liquid vial will…
IMBRUVICA® (ibrutinib) Pharmacyclics, Inc. and Janssen Biotech, Inc., are pleased to announce that, as of January 29, 2015, IMBRUVICA® (ibrutinib) has been granted regular approval by the FDA for use in patients with Waldenström’s Macroglobulinemia (WM). For updated information, please see accompanying Full Prescribing Information
FDA Approves Lanreotide For Treatment of GEP-NETs The U. S. Food and Drug Administration approved lanreotide (Somatuline Depot Injection, Ipsen Pharma) for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. Lanreotide was previously approved for the long-term treatment of acromegalic patients who…
FDA Approves BLINCYTOTM (blinatumomab) the U.S. Food and Drug Administration approved BLINCYTOTM (blinatumomab) for injection, for intravenous use. Trade Name NDC* Pack Size WAC BLINCYTOTM 55513-0160-01 35 mcg lyophilized powder, single use vial IVSS (IV Solution Stabilizer) 10 mL single use vial $ 3178.57 *Note that the product’s NDC code has been “zero-filled” to…
FDA Approves Companion Diagnostic for the Detection of BRCA1/2 Mutations in Ovarian Cancer The FDA approval of olaparib occurred concurrently with that of a companion diagnostic, BRACAnalysis CDx. This genetic test is designed to detect the presence of mutations in the BRCA genes in blood samples from patients with ovarian cancer. To read more…
FDA Approves Olaparib to Treat BRCA-Mutated Advanced Ovarian Cancer The U.S. Food and Drug Administration (FDA) today granted accelerated approval to olaparib (Lynparza) for women with advanced ovarian cancer with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, as detected by an FDA-approved test, who have been treated with three or more prior lines…
FDA Approves Gazyva® (Obinutuzumab) Supplemental Biologics License Application with New Data in Previously Untreated Chronic Lymphocytic Leukemia Genentech, a member of the Roche Group, announced that the FDA approved a supplemental biologics license application (sBLA) for Gazyva in combination with chlorambucil chemotherapy in people with previously untreated chronic lymphocytic leukemia (CLL). read corporate press release »
Keytruda Code Update Keytruda (Merck) has been assigned a Level II HCPCS C code, effective 1/1/2015. This code applies to Medicare hospital outpatient claims for dates of service on or after 1/1/2015. HCPCS Code : C9027 For more information click here.
FDA Approves Opdivo for Advanced Melanoma The U.S. Food and Drug Administration today granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs. Read press release Click to read Opdivo Announcement For more information Opdivo
© 2021 FLASCO | Premium Website Design by The HDG
