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.
ELITEK Pivotal Trial Overview
ELITEK (Sanofi-Genzyme) is indicated for the initial management of plasma uric acid levels in patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. ELITEK is indicated only for a single course of treatment.
Read pivotal trial overview.
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.
Sanofi Introduces the Libtayo Surround Online Portal
Healthcare providers can now help patients enroll in LIBTAYO Surround online portal.
Click here for more information.
FDA Approves Tabrecta for Metastatic NSCLC with METex14
On May 6, 2020, Novartis announced that the U.S. Food and Drug Administration (FDA) approved TabrectaTM (capmatinib, formerly INC280), an oral MET inhibitor for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14) as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
Read corporate press release.