MD Anderson Cancer Center and TriSalus Life Sciences are collaborating to evaluate the treatment of tumors of the pancreas and liver by integrating interventional delivery of SD-101, an investigational toll-like receptor 9 (TLR9) agonist, in combination with checkpoint inhibition immunotherapy.
FDA has approved Abecma (idecabtagene vicleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
FDA has approved Sarclisa (isatuximab-irfc) in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.
Futibatinib (TAS-120), a covalently-binding FGFR inhibitor, has received Breakthrough Therapy designation from FDA for patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements, including gene fusions.
FDA has issued a Complete Response Letter regarding Merck’s supplemental Biologics License Application seeking approval for Keytruda, Merck’s company’s anti-PD-1 therapy, for the treatment of patients with high-risk early-stage triple-negative breast cancer, in combination with chemotherapy as neoadjuvant treatment, then continuing as a single agent as adjuvant (post-operative) treatment after surgery.
Huyabio International and Bristol-Myers Squibb Co. are planning to evaluate the combination of Huyabio’s HBI-8000, an epigenetic immunomodifier, and Opdivo (nivolumab), a PD-1 blocking antibody.
The European Commission has approved Cabometyx (cabozantinib) in combination Opdivo (nivolumab) for the first-line treatment of advanced renal cell carcinoma.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending the approval of Copiktra as monotherapy for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia after at least two prior therapies and follicular lymphoma that is refractory to at least two prior systemic therapies.
FDA has approved pembrolizumab (Keytruda, Merck Sharp & Dohme Corp.) in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal (tumors with epicenter 1 to 5 centimeters above the gastroesophageal junction) carcinoma who are not candidates for surgical resection or definitive chemoradiation.
Evotec SE and Takeda Pharmaceutical Company Ltd. have entered into a multi-RNA target alliance to discover and develop RNA targeting small molecule therapeutics for highly attractive targets that are difficult to address via more conventional approaches.
