About

RETEVMO™ (selpercatinib)

May 13, 2020

RETEVMO™ (selpercatinib)

Available from Onco360, RETEVMO (selpercatinib) is FDA Approved Specifically for Patients with Advanced RET-Driven Lung and Thyroid Cancers

Onco360® has been selected by Eli Lilly to be a specialty pharmacy partner for RETEVMO (selpercatinib), a novel oral treatment for adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), for adult and pediatric patients twelve years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

“The world’s top biopharmaceutical companies, including Eli Lilly, continue to leverage Onco360’s patient-centric approach to cancer care when choosing a pharmacy network to distribute its groundbreaking new treatment in oncology,” said Paul Jardina, President and CEO, Onco360. “As a specialty pharmacy dedicated to serving people with cancer, Onco360 is honored to be selected as a distribution partner for RETEVMO. We are committed to providing outstanding care to patients who have a critical need for this therapy.”

The RET proto-oncogene encodes receptor-level protein tyrosine kinases that are involved in cellular proliferation pathways. Point mutations in RET or chromosomal rearrangements involving gene fusions of RET with various partners result in oncogenesis via abnormally overactive cellular proliferation. In-vitro, RETEVMO inhibits wild-type RET as well as mutant RET isoforms, thereby reducing cellular proliferation.

According to the National Cancer Institute (NCI), approximately 228,820 people are diagnosed with lung cancer annually, with corresponding 135,720 deaths. The five-year overall survival for lung cancer, regardless of stage and histologic subtype, is 20.5%. NSCLC represents approximately 85% of all lung cancer diagnoses. Roughly 57% of NSCLC will have metastatic disease upon initial diagnosis. RET fusions occur in 1-2% of metastatic NSCLC patients.

There are an estimated 52,890 new cases of thyroid cancer diagnosed annually, with corresponding 2,180 deaths according to the NCI. Histologic subtypes of thyroid cancer include papillary thyroid cancer (70-80% of all cases), follicular thyroid cancer (10-15% of all cases), medullary thyroid cancer (5-10% of all cases), and anaplastic thyroid cancer (<5% of all cases). The five-year overall survival, regardless of stage, for papillary thyroid cancer, follicular thyroid cancer, medullary thyroid cancer, and anaplastic thyroid cancer is 100%, 98%, 90%, and 7%, respectively. Approximately 4% of thyroid cancer patients will have metastatic disease upon initial diagnosis. The incidence of RET alterations varies dependent upon histologic subtype (i.e., 10-20% of papillary thyroid cancer cases, 90% of hereditary medullary thyroid cancer cases).

RETEVMO is marketed by Lilly USA, LLC, a division of Eli Lilly and Company, dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. The FDA’s approval of RETEVMO is based on the results of Phase I/II LIBRETTO-001 (NCT03157128) clinical trial involving 702 patients with RET-altered advanced solid tumors. RETEVMO administration resulted in a 64% overall response rate (ORR) in metastatic RET fusion-positive NSCLC patients who received prior platinum-based chemotherapy and an 85% ORR in metastatic RET fusion-positive NSCLC patients who were treatment-naïve. Additionally, RETEVMO administration resulted in a 69% ORR in patients with advanced or metastatic RET-mutant MTC previously treated with cabozantinib or vandetanib and a 73% ORR in patients with advanced or metastatic RET-mutant MTC who were cabozantinib and vandetanib -naïve. Finally, RETEVMO administration resulted in a 79% ORR in previously treated patients with RET fusion-positive advanced or metastatic thyroid cancer and a 100% ORR in untreated patients with RET fusion-positive advanced or metastatic thyroid cancer.  

Community and hospital-based oncologists can immediately place prescription orders with Onco360 for RETEVMO, as well as other cancer and supportive care medications. Referral forms and information on how to order are available at Onco360.com/Order. For full prescribing information, visit RETEVMO.com.