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RemeGen’s RC88 Receives US FDA Fast Track Designation

The United States Food and Drug Administration has granted Fast Track Designation for China-based RemeGen's RC88, a mesothelin (MSLN)-targeting antibody-drug conjugate (ADC). The investigational drug is intended for the treatment of patients diagnosed with platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancers.

Supplemental Biologics License Application for Tisotumab Vedotin Accepted for FDA Priority...

The U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for tisotumab vedotin (Tivdak®; Genmab and Pfizer) for the treatment of patients with recurrent or metastatic cervical cancer.

Priority Review for Supplemental Biologics License Application of Enfortumab Vedotin +...

The U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for priority review for enfortumab vedotin-ejfv (Padcev® ; Astellas/Seagen with pembrolizumab (Keytryuda® ( Merck & Co; Merck Sharp & Dohme/MSD) as a combination therapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC), a form of bladder cancer that has spread to surrounding organs or muscles, or other parts of the body.

Tisotumab Vedotin Significantly Prolongs Overall Survival in Patients with Recurrent/Metastatic Cervical...

Results today from the Phase 3 innovaTV 301 randomized global trial, which showed treatment with tisotumab vedotin (Tivdak®; Seagen/Genmab)* demonstrated a statistically significant and clinically meaningful 30% reduction in the risk of death in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy, compared with chemotherapy (HR: 0.70, 95% CI: 0.54-0.89, p=0.0038).[1]

AstraZeneca Enters License Agreement with KYM Biosciences for CMG901

AstraZeneca has signed an exclusive global license agreement with KYM Biosciences, a joint venture of Keymed Biosciences and Lepu Biopharma, for CMG901.

First Patient Dosed with PRO1184 and PRO1160 Cleared for Study Initiation...

Dosing has initiated in the Phase 1 first-in-human clinical trial of PRO1184 (NCT05579366),  an antibody-drug conjugates or ADC being developed by ProfoundBio comprising a folate receptor alpha-directed antibody conjugated to the exatecan payload using a novel, proprietary hydrophilic linker.

Stable, Site-Specific ADC Conjugation with SMARTag® Technology and Innovative Linker

Antibody-drug conjugates have achieved commercial success over the last 10 years with 15 therapies launched globally to date, including 11 with U.S. FDA approval, and two biosimilars. With their ability to direct highly potent cytotoxic payloads selectively to target cells, ADCs offer the prospect of more precise treatments and a reduction in off-target effects.

Zai Lab to Commercialize and Expand Patient Access to Tisotumab...

Zai Lab, a patient focused, global biopharma company committed to driving the next wave of healthcare innovation confirmed that it had signed an exclusive collaboration and...

European Medicines Agency Recommends Approval of Enfortumab Vedotin Monotherapy for Locally...

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed its previously adopted positive opinion, recommending approval...

Himalaya Therapeutics to Develop Conditionally Active Biologics for the Greater China...

Clinical-stage biopharmaceutical company Himalaya Therapeutics, focused on development and commercialization in Greater China, of a novel class of investigational antibody therapeutics for the treatment...

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