News

Below you will find relevant news links and information:

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 support@crisphealth.org), 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.