Member Announcements

Below you will find relevant member news links and information:

 

The Young Investigator Award

 

The Young Investigator Award (YIA) is a one-year, $50,000 grant that provides research funding to promising physicians to support their transition from final years of training to faculty appointment and to encourage and promote high-quality research in clinical oncology.  Conquer Cancer is now accepting applications for the 2019 Young Investigator Award (YIA). 

 

Applications in all areas of cancer research are being accepted. For 2019, Conquer Cancer has also dedicated funding for the following areas: breast cancer, cancer prevention, gastrointestinal cancer, kidney cancer, lung cancer, pediatric cancer, sarcoma, and supportive care.  Applications are due September 25, 2018, 11:59 PM (EDT). 

 

Click here for more 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.

 


FDA approves tisagenlecleucel for adults with relapsed or refractory large B-cell lymphoma

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).
Click here for the source article.

FDA approves abiraterone acetate in combination with prednisone for high-risk metastatic castration-sensitive prostate cancer
Food and Drug Administration (FDA) approved abiraterone acetate (Zytiga, Janssen Biotech Inc.) tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer (CSPC). FDA initially approved abiraterone acetate with prednisone in 2011 for patients with metastatic castration-resistant prostate cancer (CRPC) who had received prior chemotherapy, and expanded the indication in 2012 for patients with metastatic CRPC.  
Click here for the source article.

FDA approves lutetium Lu 177 dotatate for treatment of GEP-NETS
Food and Drug Administration approved lutetium Lu 177 dotatate (LUTATHERA, Advanced Accelerator Applications USA, Inc.) a radiolabeled somatostatin analog, for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.
Click here for the source article.

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.
Click here for the source article.

FDA approves olaparib for germline BRCA-mutated metastatic breast cancer
FDA granted regular approval to olaparib tablets (Lynparza, AstraZeneca Pharmaceuticals LP), a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting.
Click here for the source article.

Nilotinib label update
FDA updated the product label for nilotinib (Tasigna, Novartis Pharmaceuticals Corp.) to include information on nilotinib discontinuation, post-discontinuation monitoring criteria, and guidance for treatment re-initiation in patients taking nilotinib for Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) who have achieved a sustained molecular response (MR 4.5).

Click here for the source article.

FDA grants marketing approval to FoundationOne CDx in vitro diagnostic
Food and Drug Administration granted marketing approval to the FoundationOne CDx (F1CDx, Foundation Medicine, Inc.), a next generation sequencing (NGS) based in vitro diagnostic (IVD) to detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type.
Click here for the source article.

FDA approves Ogivri as a biosimilar to Herceptin
Food and Drug Administration approved Ogivri (trastuzumab-dkst, Mylan) as a biosimilar to Herceptin (trastuzumab, Genentech, Inc.) for the treatment of patients with HER2-overexpressing breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).  Click here for the source article.

FDA grants regular approval to Cabometyx for first-line treatment of advanced renal cell carcinoma
Food and Drug Administration granted regular approval to cabozantinib (Cabometyx, Exelixis, Inc.) for treatment of patients with advanced renal cell carcinoma (RCC). Click here for the source article.

FDA grants accelerated approval to bosutinib for treatment of newly-diagnosed PH+ CML
Food and Drug Administration granted accelerated approval to bosutinib (BOSULIF, Pfizer Inc.) for treatment of patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML).  Click here for the source article.

FDA grants regular approval to nivolumab for adjuvant treatment of melanoma
Food and Drug Administration granted regular approval to the anti-PD1 monoclonal antibody, nivolumab (OPDIVO, Bristol-Myers Squibb Company) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection. Nivolumab was previously approved for the treatment of patients with unresectable or metastatic melanoma.  Click here for the Source Article.

FDA grants regular approval to pertuzumab for adjuvant treatment of HER2-positive breast cancer
Food and Drug Administration granted regular approval to pertuzumab (PERJETA, Genentech, Inc.) for use in combination with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.  Click here for the Source Article.

FDA approves hydroxyurea for treatment of pediatric patients with sickle cell anemia
Food and Drug Administration granted regular approval to hydroxyurea (Siklos, Addmedica) to reduce the frequency of painful crises and the need for blood transfusions in pediatric patients from 2 years of age and older with sickle cell anemia with recurrent moderate to severe painful crises.  Click here for the Source Article.

 

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
Click here to download information about this new service including patient access and reimbursement services for Pfizer Oncology.

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.
CRISP has deployed a new PDMP Registration Homepage. Prescribers with an active CDS permit and DEA number may utilize the new Auto-Registration workflow. Pharmacists and all other prescribers may utilize the Standard Registration workflow. Prescribers can check their PDMP registration status from the PDMP Registration homepage under the Am I Already Registered for PDMP? tab or may contact CRISP (877-952-7477 or [email protected]), and will receive a unique PDMP Registration code to confirm registration status.

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
Through a notice on its website, the Drug Enforcement Administration (DEA) recently announced significant changes to its registration renewal process. Effective January 1, 2017, the DEA is eliminating the informal grace period which the agency has previously allowed for registrants to renew their registrations. Only one renewal notice will be sent to each registrant’s “mail to” address approximately 65 days prior to the expiration date; no other reminders to renew the DEA registration will be provided. The notice also advises that online capability to renew a DEA registration after the expiration date will no longer be available, and that failure to file a renewal application by midnight EST of the expiration date will result in the “retirement” of the registrant’s DEA number. The original DEA registration will not be reinstated. In addition, paper renewal applications will not be accepted the day after the expiration date. If DEA has not received the paper renewal application by the day of the expiration date, mailed in renewal applications will be returned and the registrant will have to apply for a new DEA registration. 

The American Medical Association (AMA) has strongly expressed its concerns to DEA about this change in policy and the problems it could create for both patients and their physicians through letters sent Friday, December 9 to DEA Acting Administrator Charles Rosenberg and Louis Milione (Assistant Administrator for Diversion Control). These letters urged DEA to reverse the change to the renewal process.

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.