CHMP recommends approval of Calquence plus chemoimmunotherapy for first-line mantle cell lymphoma

FDA approves Blenrep combination for relapsed/refractory multiple myeloma after two or more lines of therapy

FDA approved Blenrep (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

October 24, 2025

Vol.51 No.39

Drugs & Targets

CHMP adopts positive opinion for Libtayo as adjuvant treatment for high-risk CSCC

Regeneron Pharmaceuticals announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for Libtayo (cemiplimab) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation. Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells.

October 24, 2025

Vol.51 No.39

Clinical Roundup

Outpatient administration of CAR T-cell therapy shows promising outcomes for lymphoma

The ZUMA-24 phase II clinical trial demonstrates the safety and feasibility of administering Yescarta (axi-cel) in the outpatient setting when treating relapsed or refractory large B-cell lymphoma.

September 19, 2025

Vol.51 No.34

Drugs & Targets

FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer

FDA approved gemcitabine intravesical system (Inlexzo) for adults with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.

September 19, 2025

Vol.51 No.34

Drugs & Targets

FDA approves Bosaya and Aukelso, denosumab biosimilars, for osteoporosis

FDA approved Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq) injections, biosimilars of Prolia and Xgeva respectively, for the treatment of osteoporosis. In addition, FDA granted provisional interchangeability designation for both Bosaya and Aukelso.

September 19, 2025

Vol.51 No.34

Cancer Policy

FDA will speed up public release of Complete Response Letters

FDA is shortening its timeline for publicizing Complete Response Letters, pledging to make them available to the public “promptly” after sponsors receive notice.

September 05, 2025

Vol.51 No.32

By Sara Willa Ernst

CHMP recommends approval of Calquence plus chemoimmunotherapy for first-line mantle cell lymphoma

YOU MAY BE INTERESTED IN

FDA approves Blenrep combination for relapsed/refractory multiple myeloma after two or more lines of therapy

CHMP adopts positive opinion for Libtayo as adjuvant treatment for high-risk CSCC

Outpatient administration of CAR T-cell therapy shows promising outcomes for lymphoma

FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer

FDA approves Bosaya and Aukelso, denosumab biosimilars, for osteoporosis

FDA will speed up public release of Complete Response Letters

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