New FDA Approval for Empliciti

On November 6, 2018 Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved Empliciti (elotuzumab) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.

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Click Here to read the Prescribing Information

New FDA Approval for KEYTRUDA®

On October 30, 2018 Merck announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) based on results from the KEYNOTE-407 trial. In the pivotal Phase 3 trial of patients regardless of tumor PD-L1 expression status, KEYTRUDA in combination with chemotherapy (carboplatin and either paclitaxel or nab-paclitaxel) significantly improved overall survival (OS), reducing the risk of death by 36 percent compared to chemotherapy alone (HR=0.64 [95% CI, 0.49, 0.85]; p=0.0017). This approval marks the first time an anti-PD-1 regimen has been approved for the first-line treatment of squamous NSCLC regardless of tumor PD-L1 expression status.

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Click Here for the Keytruda Medication Guide

New FDA Approval for KEYTRUDA®

On November 9, 2018 Merck announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

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Click Here to read the Keytruda Medication Guide

New NCCN Breast Cancer Guidelines Elevate Oncotype DX Breast Recurrence Score® as the Only Preferred Multi-gene Test to Predict Chemotherapy Treatment

On Oct. 9, 2018, Genomic Health, Inc., announced that its Oncotype DX Breast Recurrence Score® test has been categorized as the only "preferred" test for chemotherapy treatment decision-making for patients with node-negative early-stage breast cancer by the National Comprehensive Cancer Network (NCCN) in its 2018 guidelines for invasive breast cancer chemotherapy treatment. The only test elevated to "strongly consider" guideline inclusion with level 1 evidence, Oncotype DX continues to be distinguished as the only genomic test predictive of chemotherapy benefit. 

NCCN's guidelines update follows the recent publication of results of Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, led by ECOG-ACRIN Research Group. The largest adjuvant treatment breast cancer trial to date, TAILORx involved 10,273 women across 1,100 trial sites in six participating countries. The study results, published in The New England Journal of Medicine,  demonstrated that the Oncotype DX Breast Recurrence Score test definitively identifies the vast majority of women with early-stage breast cancer who receive no benefit from chemotherapy, and the important minority of women for whom chemotherapy benefit can be life-saving. 

Additionally, the NCCN guidelines elevated Oncotype DX into the algorithm for chemotherapy treatment of patients with micrometastases and one to three positive lymph nodes.

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Bayer Invitation to Dinner Program Oct. 17, 2018

 Aliqopa (copanlisib): A Monotherapy for 3rd Line Follicular Lymphoma

DATE:
Wednesday, October 17, 2018
   
TIME:
6:00 PM

LOCATION:
Twigs Bistro
1321 N. Columbia Center Blvd.
Kennewick, WA 99336

FEATURED SPEAKER:
Arvind Chaudhry, MD, PhD

 IF YOU’D LIKE TO ATTEND, PLEASE:
   • RSVP at www.myprogramrsvp.com,
   • Enter program number CO0167
   • Enter the state of the program location
   or
  
 • Contact Amy Araucto
   by cell phone 206-235-5411
   or email AMY.ARAUCTO@BAYER.COM
  
Please RSVP to this program by Oct 11th, 2018

New FDA Approval for LUMOXITITM

AstraZeneca and MedImmune, its global biologics research and development arm, announced that the US Food and Drug Administration (FDA) has approved LUMOXITITM (moxetumomab pasudotox-tdfk), a first-in-class CD22-directed cytotoxin, for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. LUMOXITI is not recommended in patients with severe renal impairment (CrCl ≤ 29 mL/min).

Please see complete Prescribing Information, including Boxed WARNING, Patient Information (Medication Guide), and Instructions for Use 

 Click Here to Read the Press Release

New FDA Approval for BLINCYTO®

On March 29th, 2018 the U.S. Food and Drug Administration (FDA) granted approval to BLINCYTO® (blinatumomab) for the treatment of minimal residual disease (MRD)-positive B-cell precursor Acute Lymphoblastic Leukemia (ALL).  

The FDA approved Amgen’s supplemental Biologics License Application (sBLA) for BLINCYTO® based results from the BLAST study.  

For additional information on the approval, please click here to access the full Amgen press release. 

Please see below for the Indications and Important Safety Information for BLINCYTO®.

Complete information regarding dosing and administration, warnings, precautions, safety and efficacy, can be found in the full prescribing information by clicking here.

New FDA Approval for IMBRUVICA®

On August 27, 2018 – AbbVie, a research-based global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved IMBRUVICA® (ibrutinib) plus rituximab (RITUXAN®) for the treatment of adult patients with Waldenström's macroglobulinemia (WM), a rare and incurable type of non-Hodgkin's lymphoma (NHL). With this approval, the IMBRUVICA prescribing information now includes combination use with rituximab, representing the first and only chemotherapy-free combination treatment specifically indicated for the disease. IMBRUVICA was first approved as a single agent therapy for WM in January 2015. IMBRUVICA is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.

Read the Press Release

Click here to access the complete, updated Prescribing Information