FDA Approves Keytruda for Patients with Unresectable or Metastatic MSI-H or dMMR CRC
On June 29, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck & Co.) for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).
MSI-H/dMMR testing is required prior to initiating treatment with Keytruda in these patients. For the MSI-H/dMMR indication, select patients for treatment with Keytruda as a single agent based on MSI-H/dMMR status in tumor specimens. An FDA-approved test for the detection of MSI-H or dMMR is not currently available.
Read prescribing information and medication guide.
FDA Approves Pembrolizumab for Patients with Recurrent or Metastatic cSCC
On June 24, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck & Co.) injection 100 mg for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
Read FDA announcement and prescribing information.
FDA Approves Phesgo™ Injection for Subcutaneous Use
On June 29, 2020, the U.S. Food and Drug Administration (FDA) approved pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo, Genentech) injection, for subcutaneous use.
Phesgo™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf) is indicated for use in combination with chemotherapy for:
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.
Read corporate announcement.
Billing and coding sheet.
Update: COVID-19 Emergency Food Assistance Grant Amount Change
Due to increasing demand for the program’s financial assistance, the individual grant award amount has been changed to $300 effective immediately. This adjustment will allow thousands of additional patients to receive meaningful financial support for nutritional needs while maximizing the reach of available funding as the number of people impacting by COVID 19 continues to accelerate.
To date, the COVID-19 Emergency Food Assistance Program has helped more than 13,000 patients, including 1,000 emergency food deliveries made and over 12,000 financial assistance grants being provided to patients in all 50 states.
This innovative program is a collaboration between Team Rubicon (TR) and Patient Advocate Foundation (PAF) and provides emergency food delivery and financial assistance to people living with cancer, multiple sclerosis, and rheumatoid arthritis.
Who is Eligible?
Patients with cancer, multiple sclerosis or rheumatoid arthritis who have trouble accessing or affording food or other nutritional needs due to COVID-19, with eligibility established at the point of application in most cases.
For more information, including application instructions, click here.
FDA Approves Avelumab for Maintenance Treatment in Advanced Urothelial Carcinoma
On June 30, 2020, the U.S. Food and Drug Administration (FDA) approved avelumab (Bavencio, EMD Serono, Inc.) for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.
Read FDA announcement.
FDA Approves Pembrolizumab for First-line Treatment of Metastatic MSI-H or dMMR CRC
On June 29, 2020, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co.) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
Read FDA announcement.
myBeiGene™ Patient Support
The myBeiGene™ patient support offers a customized and comprehensive support program designed to help guide and assist patients during treatment.
For more information or to enroll, click here.
Live Discussion: CD38-Directed Antibody for the Treatment of RRMM
CD38-Directed Antibody for the Treatment of Appropriate Relapsed Refractory Multiple Myeloma Patients
Thursday, June 25
5:00 PM PT
Participants of this live discussion will be able to:
Learn about the indication, mechanism of action, and important safety information for Sarclisa (isatuximab-irfc)
Gain in-depth knowledge on clinical data in adult patients with relapsed refractory multiple myeloma
Understand the dosage and administration of Sarclisa.
Learn about support available for eligible patients treated with Sarclisa.
For registration information or to learn more, click here.
Astellas and Seattle Genetics Issue Product-Specific J-code for PADCEV
Astellas and Seattle Genetics are pleased to announce the assignment of a product-specific, permanent J-code for PADCEV. CMS released the July 2020 Quarterly Healthcare Common Procedural Coding System File, which includes the designation of J9177 for PADCEV with the effective date of July 1, 2020.
Read corporate announcement.
FDA Approves Pembrolizumab for Recurrent or Metastatic cSCC
On June 24, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck & Co., Inc.) for patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
Read the FDA announcement.