New FDA Approval for KEYTRUDA®

Merck is pleased to announce that KEYTRUDA has been approved by the FDA for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic MCC. 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.

·    PD-L1 diagnostic testing is not required prior to initiating treatment with KEYTRUDA in these patients.

Before prescribing KEYTRUDA® (pembrolizumab), please read the Prescribing Information

The Medication Guide also is available.

New FDA Approval for TECENTRIQ®

Genentech is excited to share the news of a new FDA-approved indication. TECENTRIQ® (atezolizumab), in combination with Avastin® (bevacizumab), paclitaxel, and carboplatin, is now indicated for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (nsqNSCLC) with no EGFR or ALK genomic tumor aberrations.Click Here for the BFRM Quick reference.Click Here for the full prescribing information.

FDA Approves Vitrakvi® (larotrectinib)

FDA Approves Vitrakvi® (larotrectinib), the First Ever TRK Inhibitor, for Patients with Advanced Solid Tumors Harboring an NTRK Gene Fusion1,2 

• First treatment with a tumor-agnostic indication at the time of initial FDA approval

• 75% overall response rate (ORR) (95% CI, 61%, 85%) [22% complete response (CR) and 53% partial response (PR)] across various solid tumors in adults and children (N=55)2

• Adverse events (AE) of any grade observed in 20% or more of patients, regardless of attribution, included increased ALT (45%), increased AST (45%), anemia (42%), fatigue (37%), nausea (29%), dizziness (28%), cough (26%), vomiting (26%), constipation (23%), and diarrhea (22%)2

Vitrakvi will be available in oral capsules as well as a liquid formulation for adults and children.2

Bayer to Provide Comprehensive Value and Access Programs

Bayer is committed to ensuring that patients in the U.S. who are prescribed Vitrakvi are able to access the medication and receive the support they may need. As part of this commitment, Bayer is providing two comprehensive programs, the Vitrakvi Commitment ProgramTM and the TRAK AssistTM patient support program. 

The Vitrakvi Commitment Program will refund the cost of Vitrakvi to payers, patients and third-party organizations paying on behalf of patients, in the event eligible patients do not experience clinical benefit within 90 days of treatment initiation. Eligible patients include those who have tested positive for an NTRK gene fusion, have not received clinical benefit within 90 days of treatment initiation, and received Vitrakvi from an in-network specialty pharmacy.


The TRAK AssistTM patient support program provides comprehensive reimbursement support and patient assistance services. For more information and eligibility requirements, please call 1-844-634-TRAK (8725) or .

Click Here to read the Press Release.

Click Here to read the Prescribing Information. 

New J Code for Rituxan

The Centers for Medicare & Medicaid Services (CMS) has made a change to the RITUXAN® (rituximab) J-code and has assigned a permanent J-code for RITUXAN HYCELA® (rituximab/hyaluronidase human subcutaneous injection). 

Effective January 1, 2019 J-code J9312 will replace J9310 for RITUXAN and the billable units will change from 100 mg to 10 mg. 

Click Here for the RITUXAN AND RITUXAN HYCELA J-Code Flash Card provided by Genentech. 

Apple Health (Medicaid) Provider Alert

What is changing? 

There is no change to the agency’s current process for hospice 5-day notification for Washington Apple Health (Medicaid) clients. 

When does the agency require a completed hospice 5-day notification?

The agency requires a completed hospice 5-day notification form (HCA/Medicaid Hospice Notification, HCA 13-746) when the client is enrolled in hospice and resides in a nursing home, or may be admitted to a nursing home, and is one of the following: 

  • A Medicare client whose Medicaid eligibility is pending or who has not yet applied for Medicaid; or
  • A dual-eligible client (currently enrolled in Medicare and Medicaid). 

Please review the HCA/Medicaid Hospice Notification (HCA 13-746) form for complete and valid information, including current attending physician. The agency will return incomplete or incorrect forms by fax. To download an agency provider form, go to HCA’s Billers and provider’s web page, select Forms & publications.

When does the agency NOT require a completed hospice 5-day notification? 

Do not send an HCA/Medicaid Hospice Notification form to the agency for anyone who is private pay and not enrolled in Washington Apple Health (Medicaid). 

New FDA Approval for TALZENNA®

Pfizer announced the FDA approval of TALZENNA® (talazoparib) on October 16, 2018. 

Prescribing Information: click here

FDA Approves a New Dosing Frequency for  KYPROLIS® (carfilzomib) and dexamethasone

On October 1, 2018 Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to expand the Prescribing Information for KYPROLIS® (carfilzomib) to include a once-weekly dosing option in combination with dexamethasone (once-weekly Kd70) for patients with relapsed or refractory multiple myeloma. 

Click Here to read the entire Press Release

Click Here for more information on Kyprolis

FDA Approval of LORBRENA® (lorlatinib)

Pfizer Oncology is proud to announce the FDA approval of LORBRENA® (lorlatinib) on Friday, November 2, 2018.

Click here  to read the Press Release.

Visit LORBRENA U.S. Physician Prescribing Information to read the full PI.