MDCSCO Industry News

From EMD Serono Inc.: EMD Serono, Inc. is pleased to announce that on February 3, 2021 the U.S. Food and Drug Administration (FDA) approved TEPMETKO® (tepotinib). Please see Full Prescribing Information for TEPMETKO (tepotinib) for more information.

From Daiichi Sankyo and AstraZeneca: Daiichi Sankyo and AstraZeneca are excited to announce that ENHERTU® (fam-trastuzumab deruxtecan-nxki) is now approved for a new indication. ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate that was recently approved for use in adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. More information can be found here. Please be aware of the “Boxed Warnings” and other important safety information. For example, “ENHERTU has Boxed WARNINGS for Interstitial Lung Disease/Pneumonitis and Embryo-Fetal Toxicity. Please review full Prescribing Information for additional information.

From AstraZeneca: AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved TAGRISSO® (osimertinib) for adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. Find out more.

From Gilead: Gilead has announced that CMS has issued a new J-Code for TRODELVY (sacituzumab govitecan-hziy) and published the payment limits and the NDC to HCPCs cross-walk file on their website.Effective for dates of service on or after January 1, 2021, the new HCPCS code for TRODELVY is J9317 and the billing increment is 2.5 mg.Find out more.

From AstraZeneca: AstraZeneca’s IMFINZI® (durvalumab) has been approved in the US for an additional dosing option for patients with a body weight of 30 kg and more: 1500 mg administered intravenously every four weeks in the approved indication of unresectable Stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy (CRT). Patients with body weight <30 kg must receive weight-based dosing, equivalent to IMFINZI 10 mg/kg every 2 weeks. Learn more in AstraZeneca’s press release here. Click here for Important Safety Information.

From Janssen Pharmaceutical Companies of Johnson & Johnson: On December 3, 2020, Janssen announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for amivantamab, an investigational, fully-human epidermal growth factor receptor (EGFR) and mesenchymal epithelial transition factor (MET) bispecific antibody with immune cell-directing activity that targets tumors with activating and resistance EGFR and MET mutations and amplifications. Find out more.

From Lilly: As part of a national initiative to improve access to newly approved treatments, Lilly Oncology is offering a free thyroid testing program to help determine if patients have a genetic alteration that may inform therapeutic decisions. Please review the program details here.

From Taiho Oncology: Taiho Oncology announces that a corporate press release, “NCCN® Adds INQOVI® (decitabine and cedazuridine) Tablets to its Clinical Practice Guidelines in Oncology for Myelodysplastic Syndromes " has been issued on November 23, 2020. Read the press release here.

From AstraZeneca: AstraZeneca announces important dosing information for unresectable Stage III non-small cell lung cancer (NSCLC) following chemoradiotherapy. Options are available for weight-based 2-week or fixed 4-week dosing with IMFINZI, allowing patients to receive IMFINZI at the frequency that best suits their schedules. Find out more.

From Lilly: As part of a national initiative to improve access to newly approved treatments, Lilly Oncology is offering a free thyroid testing program to help determine if patients have a genetic alteration that may inform therapeutic decisions. Please review the details outlined here and save this form to request a test for your patient as the need arises.

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 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.