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Launches Bendamustine Hydrochloride Injection in the United States","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals for Bendamustine
The disappointed outcome of the confirmatory trials leads to voluntarily withdraw, in the U.S., accelerated IMBRUVICA® (ibrutinib) approvals for patients with the blood cancers mantle cell lymphoma who have received at least one prior therapy and with marginal zone lymphoma.
Bendamustine hydrochloride is a bifunctional mechlorethamine derivative containing a purine-like benzimidazole ring, which can lead to cell death via several pathways. It is active against both quiescent and dividing cells.
Under the settlement agreement, Dr. Reddy’s has the right to market its product BENDEKA® (bendamustine hydrochloride), an alkylating drug, indicated for treatment of patients with Chronic lymphocytic leukemia.
The results demonstrated TT11 to be well-tolerated with promising efficacy in relapsed or refractory (r/r) CD30-positive classical Hodgkin lymphoma (cHL). The CD30.CAR-T cell therapy was demonstrated to be well tolerated with no unexpected safety signals.
CYT-0851 is in a Phase 1/2 clinical trial as both a monotherapy and in combination with standard of care chemotherapy and has the potential to be a first-in-class MCT inhibitor. By impairing monocarboxylate transporter-mediated lactate transport, CYT-0851 disrupts glycolysis.
TT11 – is an autologous CD30 targeting CAR-T therapy currently being investigated as a potential treatment for relapsed or refractory classical Hodgkin lymphoma.
Tessa plans to use the proceeds from the financing to advance the ongoing clinical development of the company’s autologous CD30-CAR-T therapy (TT11) and allogeneic CD30.CAR EBVST therapy (TT11X) programs.
Data for CYT-0851 show that the drug has performed well in cancer patients: it has desirable pharmacologic properties with an estimated half-life of three days, dose proportional exposure, and a dose dependent, predictable, and favorable safety profile.
With a median follow-up of 84.7 months, the IMBRUVICA (Ibrutinib) plus BR and rituximab maintenance combination showed a statistically significant and clinically meaningful 2.3-year improvement in median PFS.
ADI-001 exhibited robust in vitro and in vivo tumor growth inhibition in multiple human lymphoma cell lines, with adaptive and innate mechanisms contributing to its anti-tumor activity.