Member AnnouncementsBelow you will find relevant member news links and information:
FDA approves avatrombopag for thrombocytopenia in adults with chronic liver disease Food and Drug Administration approved avatrombopag (Doptelet, AkaRx Inc.) for thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure. Approval was based on two international, identically designed, randomized, double-blind, placebo-controlled trials, ADAPT-1 and ADAPT-2. Patients (n=430) with chronic liver disease and thrombocytopenia received either avatrombopag (n=274) or placebo (n=156) daily for 5 days prior to a scheduled procedure, and had at least 1 post-dose safety assessment. Click here for more.
FDA approves Retacrit as a biosimilar to Epogen/Procrit Food and Drug Administration approved Retacrit (epoetin alfa-epbx, Hospira Inc., a subsidiary of Pfizer Inc.) as a biosimilar to Epogen/Procrit (epoetin alfa, Amgen Inc.) for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis, use of zidovudine in patients with HIV infection, and the effects of concomitant myelosuppressive chemotherapy. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. Click Here for more.
FDA approves dabrafenib plus trametinib for anaplastic thyroid cancer with BRAF V600E mutation Food and Drug Administration approved dabrafenib (TAFINLAR®, Novartis Pharmaceuticals Corp.) and trametinib (MEKINIST®, Novartis Pharmaceuticals Corp.) in combination for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options. Click Here for more.
Food and Drug Administration approved tisagenlecleucel (KYMRIAH, Novartis Pharmaceuticals Corp.) a CD19-directed genetically modified autologous T-cell immunotherapy, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Click here for more.
FDA approves dabrafenib plus trametinib for adjuvant treatment of melanoma with BRAF V600E or V600K mutations Food and Drug Administration granted regular approval to dabrafenib (TAFINLAR, Novartis Pharmaceuticals Corp.) and trametinib (MEKINIST, Novartis Pharmaceuticals Corp.) in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. Click here for more.
CMS Urged to Reduce MIPS Reporting Period to Address Notification Delays, Administrative Burden ASCO joined nearly 50 medical organizations in urging the Centers for Medicare & Medicaid Services (CMS) to reduce the quality performance period under the 2018 Merit-based Incentive Payment System (MIPS) to 90 days instead of a full calendar year. In a letter to CMS Administrator Seema Verma, the organizations point to estimates that, under provisions from the 2018 QPP final rule, record keeping and reporting will total more than 7.5 million hours and cost nearly $700 million—taking physician time and other resources away from patients. Click here for more. FDA approves osimertinib for first-line treatment of metastatic NSCLC with most common EGFR mutations Food and Drug Administration approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals LP) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. Click here for source article. DA approves fostamatinib tablets for ITP the Food and Drug Administration approved fostamatinib disodium hexahydrate tablets (TAVALISSE, Rigel Pharmaceuticals, Inc.) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Click here for the source article. FDA approves nivolumab plus ipilimumab combination for intermediate or poor-risk advanced renal cell carcinoma Food and Drug Administration granted approvals to nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb Co.) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma. Click here for the source article. FDA approves everolimus for tuberous sclerosis complex-associated partial-onset seizures Food and Drug Administration approved everolimus tablets for oral suspension (Afinitor Disperz, Novartis Pharmaceuticals Corp.) for the adjunctive treatment of adult and pediatric patients aged 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures. Everolimus is also approved for two other manifestations of TSC: TSC-associated subependymal giant cell astrocytoma (SEGA) and TSC-associated renal angiomyolipoma. Click here for the source article. FDA approves rucaparib for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer Food and Drug Administration approved rucaparib (Rubraca®, Clovis Oncology Inc.), a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Click here for the source article. FDA granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia Food and Drug Administration granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% Click here for the source article. FDA approves nilotinib for pediatric patients with newly diagnosed or resistant/intolerant Ph+ CML in chronic phase Food and Drug Administration approved nilotinib (TASIGNA, Novartis Pharmaceuticals Corporation) for pediatric patients 1 year of age or older with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. Click here for the source article. Brentuximab Vedotin Food and Drug Administration approved brentuximab vedotin (Adcetris, Seattle Genetics, Inc.) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy. Click here for the source Article. New CMS Rule Could Limit Access to Genetic Testing A proposed rule from the Center for Medicare and Medicaid Services (CMS) could restrict coverage of genetic tests for patients with cancer, particularly those with late-stage disease. If the rule is finalized, CMS would cover only U.S. Food and Drug Administration (FDA)-approved next-generation sequencing tests. Many other widely used genetic tests would no longer be available to Medicare beneficiaries. The new rule would particularly affect patients with lung cancer, for which no FDA-approved blood-based sequencing tools exist. “This proposed coverage policy is overly restrictive, and we are concerned that it could dramatically reduce patient access virtually overnight,” the American Medical Association (AMA) told CMS in a comment submitted on the draft rule. “…If not phased in with adequate lead time, [the provisions of the proposed national coverage determination] will disrupt current patient care plans and likely delay treatment – where treatment is time sensitive.” Patient advocacy groups worry that access to tests already in use will be delayed as manufacturers pursue premarket FDA approval for their devices. Click here for the source article. FDA approves apalutamide for non-metastatic castration-resistant prostate cancer Food and Drug Administration approved apalutamide (Erleada™, Janssen Biotech, Inc.) for patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). Approval was based on a multicenter, double-blind, clinical trial (SPARTAN, NCT01946204) randomizing 1,207 patients with NM-CRPC (2:1) to receive either apalutamide, 240 mg orally once daily in combination with ADT (medical castration or surgical castration) (n=806), or placebo once daily with ADT (n=401). FDA approves abiraterone acetate in combination with prednisone for high-risk metastatic castration-sensitive prostate cancer FDA approves lutetium Lu 177 dotatate for treatment of GEP-NETS FDA broadens afatinib indication FDA granted approval to afatinib (Gilotrif, Boehringer Ingelheim Pharmaceutical, Inc.) for a broadened indication in first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test. FDA approves olaparib for germline BRCA-mutated metastatic breast cancer Nilotinib label update Click here for the source article. FDA grants marketing approval to FoundationOne CDx in vitro diagnostic FDA approves Ogivri as a biosimilar to Herceptin FDA grants regular approval to Cabometyx for first-line treatment of advanced renal cell carcinoma
FDA Approval of Obinutuzumab U. S. Food and Drug Administration approved obinutuzumab (Gazyva Injection, Genentech, Inc.) for use in combination with bendamustine followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen. Obinutuzumab was previously approved for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia. Click here for the source Article. FDA Approval of Sunitinib malate Food and Drug Administration approved sunitinib malate (Sutent, Pfizer Inc.) for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy. Click here for the Source Article. FDA Approval of Dasatinib Food and Drug Administration granted regular approval to dasatinib (SPRYCEL, Bristol-Myers Squibb Co.) for the treatment of pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase. Click here for the Source Article. FDA Approved a Label change for ADCETRIS (brentuximab vedotin) Food and Drug Administration (FDA) approved a label change for ADCETRIS (brentuximab vedotin) for injection, for intravenous use. Attached is a copy of the updated US Prescribing Information (USPI) for your review. Click here for the Source Article FDA granted approval to vemurafenib for Erdheim-Chester Disease Food and Drug Administration granted regular approval to vemurafenib (ZELBORAF, Hoffmann-La Roche Inc.) for the treatment of patients with Erdheim-Chester Disease (ECD) with BRAF V600 mutation. Click here for the Source Article. Alectinib approved for (ALK) positive metastatic non-small cell lung cancer (NSCLC) Food and Drug Administration granted regular approval to alectinib (ALECENSA, Hoffmann-La Roche, Inc./Genentech, Inc.) for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.Student loan provisions in the House tax reform proposal. Click here for Source Article. FDA approves Brentuximab vedotin for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma Food and Drug Administration granted regular approval to brentuximab vedotin (ADCETRIS, Seattle Genetics, Inc.) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy. Click here for Source Article. Student loan provisions in the House tax reform proposal Possible tax code revisions are about to be taken up by the House of Representatives. The draft legislation may be revised significantly before it is brought to the House floor for a vote and many factors are in play. However, the proposal currently includes tax changes that would affect student loans. Click here for more. Pfizer Announces Approval of BESPONSA® (inotuzumab ozogamicin) Injection for IV infusion U.S. Food and Drug Administration approved inotuzumab ozogamicin (BESPONSA, Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Click here for the Source Article. FDA Approvals for BLINCYTO® (blinatumomab) U.S. Food and Drug Administration approved blinatumomab (BLINCYTO, Amgen Inc.) for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children. Click here for Source Article. FDA Approval for enasidenib (IDHIFA, Celgene Corp.) U.S. Food and Drug Administration granted regular approval to enasidenib (IDHIFA, Celgene Corp.) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test. Click here for the Source Article. Pfizer Oncology Launches New Hub for Patients Teva is excited to announce FDA acceptance of a proposed biosimilar for review in the US: Click for information. Deadline for registering for the PDMP is July 1st. FDA Approval for Keytruda, in combination with pemetrexed and carboplatin U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA®, Merck and Co., Inc.) in combination with pemetrexed and carboplatin for the treatment of patients with previously untreated metastatic non-squamous non-small cell lung cancer (NSCLC). Click here for Source Article. FDA Approval of brigatinib (ALUNBRIG tablets, Takeda Pharmaceutical Company Limited, through its wholly owned subsidiary ARIAD Pharmaceuticals, Inc.) U.S. Food and Drug Administration granted accelerated approval to brigatinib (ALUNBRIG tablets, Takeda Pharmaceutical Company Limited, through its wholly owned subsidiary ARIAD Pharmaceuticals, Inc.) for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. Click here for the Source Article. TECENTRIQ® (atezolizumab) is NOW FDA APPROVED 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. Click here for the Source Article. FDA announced the approval of BAVENCIO® (avelumab) U.S. Food and Drug Administration granted accelerated approval to avelumab (BAVENCIO, EMD Serono, Inc.) for the treatment of patients 12 years and older with metastatic Merkel cell carcinoma (MCC). Avelumab is a programmed death-ligand 1 (PD-L1) blocking human IgG1 lambda monoclonal antibody. This is the first FDA-approved product to treat this type of cancer. Click here for Source Article Keytruda Now Approved for Refractory or Relapsed Classical Hodgkin Lymphoma (cHL). 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. Click here or the Source Article. DEA Eliminates Grace Period for Registration Renewal Assignment of a product-specific Healthcare Common Procedure Coding System (HCPCS) code for Portrazza® (necitumumab) for injection. Click for more information LARTRUVO approved by FDA U.S. Food and Drug Administration granted accelerated approval to olaratumab (LARTRUVO, Eli Lilly and Company) for the treatment of patients with soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery and with a histologic subtype for which an anthracycline-containing regimen is appropriate. Click here for the Source Article.
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