IMOS 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 Janssen:  Key Takeaways from the FY 2023 Medicare Hospital Inpatient Prospective Payment System (IPPS) Proposed Rule.  More information here.

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 G1 Therapeutics:  G1 Therapeutics, Inc. secures permanent J Code for COSELA™ (trilaciclib). The code, J1448, is effective on October 1, 2021. Visit COSELA.com for more information.

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 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 G1 Therapeutics and Boehringer Ingelheim: G1 Therapeutics and Boehringer Ingelheim announce commercial availability of COSELA^TM (trilaciclib). For more information please see the press release here and visit www.COSELA.com.

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.