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FDA Approves Updated Indication for Merck’s KEYTRUDA® (pembrolizumab) for Treatment.

The Pharma Data

In addition, as part of the label update, this indication has been revised to be for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy.

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Could Keytruda/Lenvima Combo Help Treat Advanced Renal Cell Carcinoma?

The Pharma Data

The trial looked at a combination of Keytruda from Merck and Lenvima from Eisai for the treatment of advanced renal cell carcinoma (RCC). The results from KEYNOTE-581/CLEAR (Study 307) support the potential use of KEYTRUDA plus LENVIMA for the first-line treatment of advanced RCC. Merck , also known as MSD outside of the U.S.

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Keytruda/Lenvima combo shows promise in hard-to-treat cancers

The Pharma Data

However, the combo treatment performed better in certain cancers compared to others, reporting a response in 32.3% In another phase II trial, Keytruda plus Lenvima demonstrated an ORR between 9.7-32.3% of highly-treated ovarian cancer patients and 29% of previously treated TNBC patients. Source link.

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Hypoxia-Inducible Factor-2 Alpha (HIF-2?) Inhibitor WELIREG™ (belzutifan) for the Treatment of Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors

The Pharma Data

inhibitor, for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. months (range, 2.8 as assessed by IRC.

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Positive EU CHMP Opinion for Updated Label of KEYTRUDA® (pembrolizumab)

The Pharma Data

In Europe, KEYTRUDA is approved for the treatment of adult patients with advanced or metastatic urothelial carcinoma (bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 with a Combined Positive Score (CPS) ? Merck has the industry’s largest immuno-oncology clinical research program.

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BioSpace Movers & Shakers, Dec. 18

The Pharma Data

Most recently, Cadavid served as senior vice president and Head of Clinical Development at Fulcrum Therapeutics where he led the development of multiple small molecules for the treatment of genetically defined rare diseases. Previously, Mohindru was CFO and CSO of Cara Therapeutics. Earlier, she served as CSO at Curis, Inc.

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Informed Design of Bioanalytical PCR Assay Testing Parameters

PPD

These treatments use a vector to introduce the desired nucleic acid code to replace or modify protein expression or use cells to alter/restore a specific cell type. Cell and gene therapies (CGTs) are one of the fastest growing areas in human therapeutics.