SUMO Industry News

From Abbvie: Genmab and Abbvie have announced thatEPKINLY™ (epcoritamab-bysp) has been approved by U.S. FDA as the First and Only Bispecific Antibody to Treat Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL). Click here for more.

From Merck: Merck has announced an additional indication for Keytruda (pembrolizumab) Injection 100mg. Click here for more information.

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

From Exact Sciences: Exact Sciences has launched the OncoExTraTM test, a new ultra-comprehensive genomic profiling assay for advanced cancers that interrogates both DNA+RNA, revealing variants that DNA alone may miss. It uncovers rare or overlooked fusion genes and transcription variants in nearly 20K genes and detects 41% of fusions at the RNA level alone*. Results are delivered in an easy-to-interpret report with a spotlight on insights that matter most. >>Explore the test  *Retrospective analysis of 1509 clinical reports, of which 1261 included both DNA and RNA profiling. Among the 75 reports with clinically actionable RNA fusions, 31 had RNA findings only.

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 Biotheranostics, Inc., A Hologic Company:  ASCO Guidelines were updated April 19, 2022 recognizing Breast Cancer Index as the only genomic test to help inform extended endocrine therapy decisions for HR+, early-stage breast cancer patients. The update highlights the utility of Breast Cancer Index to help guide decisions around extension of TAM, AI, or TAM followed by AI, in women with both node-negative and node-positive (1-3 nodes) disease. Read More

From Epizyme:  Epizyme has launched a no cost EZH2Now Testing Program, an Epizyme initiative in collaboration with Quest Diagnostics, the leading provider of diagnostic information services, to provide free EZH2 mutation testing for patients with relapsed or refractory (R/R) follicular lymphoma (FL). Quest Diagnostics will coordinate directly with your local lab to obtain tissue for testing. Follow this link to begin the order process:

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

From Janssen: Janssen has announced the new Compass program that offers a single point of contact for patients, care partners, and professionals for navigation and support. More information here.

From Foundation Medicine: Foundation Medicine received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®Liquid CDx to be used as a companion diagnostic to aid in identifying patients with MET exon 14 skipping (METex14) in metastatic non-small cell lung cancer (NSCLC) for whom treatment with TABRECTA® (capmatinib) may be appropriate. TABRECTA® is the first therapy approved by the FDA for adult patients with metastatic NSCLC whose tumors have an alteration that leads to METex14. FoundationOne Liquid CDx analyzes the largest genomic region of any FDA-approved comprehensive liquid biopsy test and was approved by the FDA in August 2020 to report genomic alteration results for patients with any solid tumor. See the press release for full details.

From Janssen:  Janssen has announced that RYBREVANT™ (amivantamab-vmjw) is now included in the Janssen CarePath Savings Program. Eligible patients pay just $5 for each infusion and receive savings on their out-of-pocket medication costs, including deductible, co-pay, and co-insurance for their Janssen medication, up to a $26,000 maximum program benefit per calendar year. There is no income requirement. More information here.

From Janssen: FDA has approved RYBREVANT™ for the treatment of adult patients with metastatic NSCLC with EGFR exon 20 insertion mutations. This news is based on results from the Phase 1 CHRYSALIS study and follows the FDA’s decisions in March 2020 to grant Breakthrough Therapy Designation and in December 2020 to initiate Priority Review of the Biologics License Application. This approval makes RYBREVANT™ the first fully-human, bispecific antibody authorized for the treatment of patients with NSCLC that targets EGFR exon 20 insertion mutations, which are the third most prevalent activating EGFR mutation. See the Janssen news release here and view the announcement on Twitter here.

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

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 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.