New Labeling Approved for XTANDI

On October 21, 2016, Astellas Pharma Inc. and Pfizer Inc. announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to update the U.S. product labeling for XTANDI® (enzalutamide) capsules to include new clinical data versus bicalutamide from the TERRAIN study. The data demonstrate improvement in radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (CRPC) who were treated with enzalutamide compared to patients who were treated with bicalutamide.

Click Here for the XTANDI Clinical Launch Announcement. 

New FDA approval for LARTRUVO™ (olaratumab)

On October 19, 2016, the US Food and Drug Administration (FDA) approved LARTRUVO™ (olaratumab) injection, 10 mg/mL solution. LARTRUVO is indicated, in combination with doxorubicin, for the treatment of adult patients with soft tissue sarcoma (STS) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery.

This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

Click here for full Prescribing Information and see below for Important Safety Information for LARTRUVO.

KEYTRUDA Receives New Approval for mNSCLC

Merck is pleased to announce that KEYTRUDA is now the only anti–PD-1 approved for first-line treatment of mNSCLC with high PD-L1 expression (TPS ≥50%). In the KEYNOTE-024 study, KEYTRUDA demonstrated superior survival in the first-line treatment  of mNSCLC vs platinum-containing chemotherapy in patients whose tumors expressed high levels of PD-L1 (TPS ≥50%).

For more information:

Click Here to read the Press Release

Click Here to read the Announcement Letter

KEYTRUDA Prescribing Information

KEYTRUDA Medication Guide

CMS Assigns Unique C-code to TECENTRIQ™

A unique C-code that was recently assigned to TECENTRIQ™ (atezolizumab) by the Centers for Medicare & Medicaid Services (CMS). The C-code for TECENTRIQ is C9483 (Injection, atezolizumab, 10 mg).
The unique C-code goes into effect on October 1, 2016. Payers may require its use until a permanent J-code is assigned. The permanent J-code is expected to be available for use starting on January 1, 2018.
The C-code is used primarily in the Medicare hospital outpatient setting. However, some payers accept this C-code instead of unclassified J- or C-codes when billing for TECENTRIQ. Please check with your payers to verify codes and special billing requirements.

Click Here for the TECENTRIQ Billing and Coding Flash Card which contains additional information about coding and billing. Click Here for the full TECENTRIQ Prescribing Information. Dedicated Specialists at TECENTRIQ Access Solutions can be reached at (888) 249‐4918, or visit Genentech-Access.com/TECENTRIQ for more information.

Taiho Patient & Reimbursement Assistance Programs

Taiho Oncology Patient Support offers the following services: 

• Co-pay support for eligible, privately insured patients. Such patients can receive a Taiho Oncology Patient Support Co-pay Card for help with out-of-pocket expenses. 

• Patient Assistance Program. Taiho Patient Support will research financial assistance options for patients with no insurance coverage, insuffi­cient prescription coverage, or insufficient resources to pay for treatment with Lonsurf. Eligible patients may receive Lonsurf at no cost based on assistance, financial, and medical criteria. 

• Alternate funding support. Taiho Patient Support will also refer eligible, publicly insured patients to nonprofit founda­tions that may be able to offer them co-pay assistance.

Click Here for more information on these programs.

Merck's KEYTRUDA Recieves New Indication

On August 5, 2016 Merck announced that the FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum-Containing Chemotherapy.

Please click on the links below for additional information:

Press Release

FDA Approval Letter

Announcement Lette

You are cordially invited to participate in a national webcast followed by a clinical case discussion at select locations, for more information click here. 

Additional Formulation and Indication for EMEND

Merck is pleased to announce that EMEND for oral suspension is now available.

Please click on the links below for more information:

Merck EMEND Announcement Letter 

Prescribing Information

Patient Information

Instructions for Use

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.