FDA Approval for Heron Therapeutics SUSTOL®

On Aug. 10, 2016 Heron Therapeutics, Inc. (NASDAQ:HRTX), announced that the U.S. Food and Drug Administration (FDA) has approved SUSTOL® (granisetron) extended-release injection. SUSTOL is a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.

SUSTOL is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Heron’s Biochronomer® polymer-based drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days, covering both the acute and delayed phases of chemotherapy-induced nausea and vomiting (CINV).

Click here to read the press release from Heron Therapeutics, Inc. 

CMS Preliminary Decision - Unique J Code for BENDEKA

On April 19, 2016, The Center for Medicare & Medicaid Services (CMS) published a preliminary decision on the HCSPCS application for a unique J code for BENDEKA® (bendamustine hydrochloride) Injection, a ready-to-dilute solution, low-volume (50 mL) bendamustine formulation. CMS ruled that the current J code for TREANDA® (bendamustine HCl) (J9033) appropriately describes BENDEKA. 

This is a preliminary decision and the final CMS decision is expected in the fourth quarter. If a unique J code is recommended at that time for BENDEKA, the effective date would be January 1, 2017.  

As a result of this preliminary ruling, some payers may reimburse BENDEKA using either the J9999 or the J9033 code.  You must adhere to the payer recommendations to determine which code to use for BENDEKA patients. Whatever your decision is regarding coding, it will be important to ensure that the BENDEKA NDC is used on every claim.  

Click here for more information on BENDEKA from Teva. 

New FDA Approval for Opdivo®

On Tuesday, May 17, 2016, Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration (FDA) has approved Opdivo®(nivolumab) for the treatment of patients with classical Hodgkin lymphoma (cHL) who have relapsed or progressed after autologous hematopoietic stem cell transplantation (auto-HSCT) and post-transplantation brentuximab vedotin.This accelerated approval is based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Click Here to read the Press Release from Bristol-Myers Squibb. 

Webcast Invitation from OptumHealth

OptumHealth invites you to participate in the live webcast, Optimal Clinical Strategies for the Treatment of Relapsed Hodgkin’s Lymphoma. 

Please join us on Tuesday, June 14, 2016.
1–2 p.m. Eastern
12–1 p.m. Central
11 a.m.–12 p.m. Mountain
10–11 a.m. Pacific

Intended Audience

This activity is designed to meet the educational needs of physicians, nurses, pharmacists and other health care professionals (HCPs) who have an interest in relapsed Hodgkin’s lymphoma (rHL).

Click Here to view this invitation online. 

New FDA Approval for TECENTRIQ (atezolizumab)

TECENTRIQ (atezolizumab) is NOW FDA APPROVED for the treatment of patients with locally advanced or metastatic urothelial cell carcinoma who:

  • Have disease progression during or following platinum-containing chemotherapy
  • Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
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 confirmatory trials.
FDA designated TECENTRIQ a “Breakthrough Therapy” in May 2014. This designation is intended to expedite the development and review of medicines intended to treat serious or life-threatening diseases.

Please see the attached announcement for additional information, including NDC and ICD-10 codes:
Prescribing Information
NDC and ICD-10 Code Information

Information on Merck's KEY+YOU Support Program

The KEY+YOU Support Program provides patients and their caregivers with support 24/7 throughout their treatment with KEYTRUDA®(pembrolizumab) injection 100 mg. The program gives patients and caregivers the option of talking with an experienced nurse who offers support by telephone and/or receiving resources by e-mail. KEY+YOU nurses can provide general information about KEYTRUDA. Enrollees are notified that the information provided through the KEY+YOU Support Program does not take the place of talking to their doctor or health care team, and are actively instructed to contact their health care team if treatment questions are asked. 

Please click on the link below or call 85-KEYTRUDA (855-398-7832) for information about the KEY+YOU Patient Support Program from Merck. 


KEY+YOU Support Program


FDA Approves supplemental New Drug Application for Gilotrif®

On April 15, 2016, Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Gilotrif® (afatinib) tablets for the treatment of patients with advanced squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy. The U.S. approval follows the recent marketing authorization of Gilotrif in this patient population by the European Commission. Gilotrif, an oral, once-daily EGFR-directed therapy, is currently approved in the U.S. for the first-line treatment of specific types of EGFR mutation-positive NSCLC.

Click Here to read the entire Press Release from Boehringer Ingelheim.

Dinner Program Hosted by Alexion

Alexion is hosting a dinner program, "Updates in the Understanding of Paroxysmal Nocturnal Hemoglobinuria (PNH)", presented by Richard Kelly, MD, St. James Institute of Oncology, Leeds, UK.

The program will be held at Daniel's Broiler on Thursday, May 19, 2016 at 6:30pm.

Click Here for registration information for this program.