FDA Approves Inqovi Tablets for Adults with Intermediate and High-Risk Myelodysplastic Syndromes

On July 7, 2020, the U.S. Food and Drug Administration (FDA) and Health Canada have approved decitabine and cedazuridine (Inqovi, Astex Pharmaceuticals, Inc.; Taiho Oncology, Inc.; and Otsuka Pharmaceutical Co., Ltd.) tablets for the treatment of adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML).

Approval was based on data from the ASCERTAIN phase 3 study and supporting phase 1 and 2 clinical studies. The ASCERTAIN phase 3 study evaluated the five-day, decitabine exposure equivalence between oral Inqovi^® and intravenous decitabine. The safety and efficacy of Inqovi^® was also assessed in the clinical studies.

Read corporate announcement. 

Posted 7/17/2020

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. 

Posted 7/17/2020

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. 

Posted 7/14/2020

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.

Prescribing information.

Posted 7/14/2020

FDA Approves Decitabine + Cedazuridine Oral Combo for Adult MDS

On July 7, 2020, the U.S. Food and Drug Administration (FDA) approved an oral combination of decitabine and cedazuridine (Inqovi, Astex Pharmaceuticals, Inc.) for adult patients with myelodysplastic syndromes (MDS) including the following:

• previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and
• intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.

Enhertu Receives Permanent J-Code

Effective July 1, 2020, ENHERTU^® (fam-trastuzumab deruxtecan-nxki) has a permanent j-code: J9358. ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2–based regimens in the metastatic setting.

For full prescribing information, click here. 

Posted 7/7/20

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.  

Posted 7/2/2020

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.

Posted 6/30/2020

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. 

Posted 6/25/2020

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.

Posted 6/25/20