IMOS Industry News

From AbbVie: AbbVie announces that the U.S. Food and Drug Administration has granted full approval of VENCLEXTA® (venetoclax tablets) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Find out more.

From Immunomedics: Immunomedics announces a new C-Code (C-9066) for Trodelvy (sacituzumab govitecan-hziy), a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.The C-Code is effective October 1, 2020. Find out more.

From Incyte: On August 7, 2020, the U.S. Food and Drug Administration granted accelerated approval to tafasitamab-cxix (MONJUVI, MorphoSys US Inc.), a CD19-directed cytolytic antibody, indicated in combination with lenalidomide for adult patients with relapsed or refractory 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. Find out more.

From Johnson & Johnson: As our healthcare industry rapidly evolves to address the COVID-19 pandemic, new health policies and resources especially in the areas of patient affordability, care delivery and provider reimbursement continue to be released. That is why we have engaged Avalere, the health policy research firm, to develop and update a repository cataloging significant health policy changes. The repository will identify the topics covered with links to additional information where appropriate and will be updated on a regular basis. Please visit the COVID – 19 Guide for Patients and Providers on the Avalere site at this link. Find out more.

From Astellas and Seattle Genetics: Astellas and Seattle Genetics are pleased to announce the assignment of a product-specific, permanent J-code for PADCEV. The Centers for Medicare & Medicaid Services (CMS) released the July 2020 Quarterly Healthcare Common Procedural Coding System (HCPCS) File, which includes the designation of J9177 for PADCEV with the effective date of July 1, 2020. Find out more.

From Takeda: Takeda is pleased to announce that the US Food and Drug Administration (FDA) has approved the label expansion for ALUNBRIG® (brigatinib) to include patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who are tyrosine kinase inhibitor (TKI)-naive. ALUNBRIG is indicated for the treatment of adult patients with ALK+ metastatic NSCLC as detected by an FDA-approved test.  Please click here to review full prescribing information on ALUNBRIG. Click here for important safety information.

From Taiho Oncology: Taiho Oncology is excited to share that INQOVI®, (decitabine and cedazuridine) tablets, approved in July 2020, (https://www.taihooncology.com/us/news/2020-07-inqovi-approval/) is now available. Please click HERE for more information.