CMS to Release Permanent J-Code for Phesgo™ Injection

Pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo™, Genentech) injection for subcutaneous use will be issued a permanent J-Code that can be used starting January 1, 2021.

This single code (J9316) is to be used for all PHESGO patients and dosage strengths. 

Indications

Early Breast Cancer 
Phesgo™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf) is indicated for use in combination with chemotherapy for

• The neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node-positive) as part of a complete treatment regimen for early breast cancer (EBC); and

• The adjuvant treatment of adult patients with HER2-positive early breast cancer (EBC) at high risk of recurrence.

Select patients for therapy based on an FDA-approved companion diagnostic test.

Metastatic Breast Cancer  
Phesgo™ is indicated for use in combination with docetaxel for the treatment of adult patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

Select patients for therapy based on an FDA-approved companion diagnostic test.

See prescribing information.

Posted on 11/19/2020

FDA Approves Pembrolizumab + Chemotherapy for TNBC

Registration Open: Jakafi (ruxolitinib) Product Theater

Intervening With Jakafi^® (ruxolitinib) to Achieve Durable Count Control: Real-World Patient Case Discussion 

Jakafi^® (ruxolitinib) is indicated for the treatment of patients with polycythemia vera who have had an inadequate response to—or are intolerant of—hydroxyurea; patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF; and for the  treatment of steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older.

Join a one-hour live presentation—sponsored by Incyte Corporation—to learn more about the use of Jakafi^® (ruxolitinib) in treating your patients. 

Monday, November 30
12:00 - 1:00 PM EST

Presented by:
Solomon Hamburg, MD, PhD
Clinical Professor of Medicine, Division of Hematology-Oncology, Department of Medicine
UCLA Beverly Hills Hematology Oncology
REGISTER

Monday, November 30
3:00 - 4:00 PM EST

Presented by:
Jonathan Abbas, MD
Director, Acute Leukemia Program
Tennessee Oncology
REGISTER

FDA Accepts for Priority Review Cemiplimab-rwlc for Advanced NSCLC

On Thursday, October 29, the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor cemiplimab-rwlc (Libtayo^®, Regeneron Pharmaceuticals, Inc.) to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression.

The target action date for the FDA decision is February 28, 2021.

Read press release. 

Posted on 10/29/2020.

FDA Approves Expanded Indication of Pembrolizumab for R/R cHL

Ibrutinib for the Treatment of Adult Patients with CLL/SLL

Read efficacy study and prescribing information. 

To help guide and assist patients during treatment, Pharmacyclics the YOU&i^TM Support Program, which provides information on insurance coverage and out-of-pocket costs, and what to expect while on treatment.

Posted on 10/07/2020

Exelixis Access Services® EASE

Exelixis Access Services^® (EASE) provides a variety of support to help your patients get started on cabozantinib (Cabometyx^®)as soon as possible. EASE can help meet the unique needs of your patients and practice at each step along the access journey. 

Posted 10/02/2020

Cabozantinib Prescribing Information and Resources

Exelixis has issued prescribing information for cabozantinib (Cabometyx^®), which is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) and patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib as well as a series of resources that you can utilize in your practice. 

Access Prescribing Information and Resources.

Posted 10/02/2020

FDA Approves Nivolumab + Ipilimumab Immunotherapy Treatment for Mesothelioma

On October 2, 2020 the U.S. Food and Drug Administration (FDA) approved the combination of Opdivo® (nivolumab) and Yervoy® (ipilimumab) as a first-line treatment for adult patients with unresectable malignant pleural mesothelioma.

Read the FDA Announcement.

Read the Bristol Myers Squibb Announcement.

Posted 10/5/2020 

FDA Approves Two Liquid Biopsy Companion Diagnostics for Osimertinib

On August 7, the U.S. Food and Drug Administration (FDA) approved FoundationOne^® Liquid CDx and Guardant360^® CDx as next generation sequencing based liquid biopsy companion diagnostics for osimertinib (Tagrisso^®) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test; and for patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

See full prescribing information.

About FoundationOne^® Liquid CDx.

About Guardant360^® CDx.

Posted 9/24/2020