IMOS Industry News:

From Seagen:  Seagen is excited to share new PFS information. Contact Carla Taylor with Seagen Inc. for additional information and questions.

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 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 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 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 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.