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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.

Enfortumab vedotin + Pembrolizumab Approved by US FDA as the First...

Enfortumab vedotin + Pembrolizumab Approved by US FDA as the First and Only ADC + PD-1 Combination to Treat Advanced Bladder 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.

Advances in the Development of Dual-Drug Antibody Drug Conjugates

Antibody drug conjugates (ADCs) are touted for their ability to site selectively deliver a small molecule chemotherapeutic directly to a tumor cell, bypassing off target side effects from systemic circulation. To date, eleven ADCs have been FDA approved in the United States and >200 more in the clinical pipeline (clinicaltrials.gov).

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...

How an ADC with Intracellular Drug Release Properties Demonstrates Specific Cytotoxicity...

T-cell acute lymphoblastic leukemia or T-ALL is a biologically distinct form of leukemia. It's distinct from its B lymphoblastic or B-ALL counterpart and shows...

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