FDA Approves Tafasitamab-cxix + Lenalidomide for R/R DLBCL

On July 31, 2020 MorphoSys and Incyte announced that the U.S. Food and Drug Administration (FDA) has approved Monjuvi® (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.

Read corporate press release.

Read FDA announcement.

Posted 8/3/20

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

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

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

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.

Posted 6/24/2020

FDA Approves Cyramza for First-Line Treatment of Metastatic EGFR-Mutated NSCLC

On May 29, 2020, the U.S. Food and Drug Administration (FDA) approved ramucirumab injection, 10 mg/mL solution (Cyramza^®, Eli Lilly and Company) in combination with erlotinib, for the first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. With this approval, cyramza has now received six FDA approvals to treat certain types of lung, liver, stomach and colorectal cancers.

Read the press release. 

Posted 6/22/2020