ACC Industry News

From Merck: Merck has announced an additional indication for Keytruda (pembrolizumab). Click here for more information.

From BeiGene: For appropriate business and planning purposes, BeiGene USA, Inc. would like to direct your attention to this link for the December 13, 2022 press release highlighting late-breaking clinical information presented at the 2022 American Society of Hematology (ASH) Annual Meeting: click here.

From Servier:  Recently, Servier shared some information about access of ASPARLAS® (calaspargase pegol-mknl) and ONCASPAR® (pegaspargase), and wanted to ensure providers are aware of the changes Servier is making in the coming months. On December 1st, 2022 Servier will begin the transition to ASPARLAS as the only available PEGylated asparaginase for patients 1 month to 21 years of age. ONCASPAR will continue to be available for patients aged 22 years and older, managed through a new HUB. Please see link:

From BeiGene: BeiGene Clinical Data Presentations at 2022 ASCO Annual Meeting Demonstrate Mature and Growing Oncology Portfolio. Read the full press release HERE. May 26, 2022.

From Servier: On May 25, 2022, the U.S. Food and Drug Administration (FDA) approved TIBSOVO® (ivosidenib tablets) in combination with azacitidine for the treatment of patients with newly diagnosed IDH1-mutated acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. With this approval, TIBSOVO is the first therapy targeting cancer metabolism approved in combination with azacitidine for patients with newly diagnosed IDH1-mutated AML, and represents a major advancement for patients with newly diagnosed IDH1-mutated acute myeloid leukemia in the United States. here. To learn more, read the press release announcement HERE. May 25, 2022.

From Daiichi Sankyo: Daiichi Sankyo received approval by the US Food and Drug Administration (FDA) for Injectafer® (ferric carboxymaltose injection) for the treatment of iron deficiency anemia (IDA) in pediatric patients 1 year of age and older who have intolerance to oral iron or have had unsatisfactory response to oral iron. For patients weighing less than 50 kg, the recommended dosage is Injectafer 15 mg/kg body weight intravenously in two doses separated by at least 7 days per course.  More information can be found in the press release.

From Servier: Beginning February 14, 2022, there is a new NDC number for TIBSOVO® (72694-0617-60)*, the old NDC number was 71334-0100-01. SERVIER has new product packaging. The product itself remains the same. Listed here are pictures of the updated product packaging and ordering information.

From Gilead: FDA grants accelerated approval to TRODELVY® for the treatment of metastatic urothelial cancer. Click here for more information.

From BeiGene: BeiGene has announced that BRUKINSA was updated in the NCCN Treatment Guidelines for CLL to Category 2A. January 20, 2022.

From Gilead: FDA Approves TRODELVY®, the first treatment for metastatic triple-negative breast cancer shown to improve progression-free survival and overall survival. Click here for more information.

From Sanofi: Sanofi is pleased to announce that SARCLISA® (isatuximab-irfc) is now approved, in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. For more information, click here. Read the press release .

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.