ISCO Corporate Member News & FDA Approvals
From Pfizer - 8.17.2023
Pfizer Oncology is proud to announce the FDA approval of ELREXFIO™ (elranatamab-bcmm).
From AbbVie - 5.23.23
On May 19, 2023, AbbVie (NYSE: ABBV) announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLYTM (epcoritamab-bysp), as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B–cell lymphoma (HGBL), after two or more lines of systemic therapies. Learn more here.
From Pharmacyclics - 5.15.23
From Novartis - 5.8.23
On January 27, 2023, the National Comprehensive Cancer Network® (NCCN®) revised its guidelines—now Ribociclib (KISQALI®) is the only CDK4/6 inhibitor in combination with an AI designated as a Category 1 Preferred regimen in first-line HR+/HER2- mBC.1,2. Learn more here.
From Sanofi - 4.25.23
From Gilead - 2.17.23
On February 3, 2023, the Food and Drug Administration (FDA) approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. Find out more here.
From AstraZeneca - 1.30.23
On January 26, 2023, the FDA stated EVUSHELD (tixagevimab co-packaged with cilgavimab) is not currently authorized for Emergency Use for pre-exposure prophylaxis (prevention) of COVID-19 in the US until further notice, due to the sustained high frequency of circulating SARS-CoV-2 variants that Evusheld does not retain in vitro neutralization against. You can view the full statement from AstraZeneca here.
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.
From Regeneron: 11.9.22 - LIBTAYO® (cemiplimab-rwlc) is now FDA-approved in combination with platinum-based chemotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) whose tumors have no EGFR, ALK, or ROS1 aberrations, and is 1) Locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, OR 2) Metastatic.
On August 24, 2022, the Food and Drug Administration approved ibrutinib (Imbruvica, Pharmacyclics LLC) for pediatric patients ≥ 1 year of age with chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension. For more information, read the FDA Announcement or Press Release.
AZ Oncology ID is your resource for biomarker testing to help patients receive the most appropriate, personalized treatment.
FDA approved cabozantinib (CABOMETYX, Exelixis, Inc.) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. More Information, January 14, 2019