EC approves Lynozyfic for treatment of r/r multiple myeloma

Teclistamab improves outcomes in relapsed MM, phase III trial finds

An international phase III study showed that patients with relapsed multiple myeloma treated with teclistamab lived longer and remained in remission significantly longer than patients receiving standard therapies.

June 05, 2026

Vol.52 No.22

Drugs & Targets

European Commission authorizes expanded label for Venclyxto to include additional combinations in previously untreated CLL

The European Commission authorized an expanded label for Venclyxto (venetoclax) to include use in combination with acalabrutinib (with or without obinutuzumab) and use in combination with ibrutinib for the treatment of adult patients with previously untreated chronic lymphocytic leukemia.

June 05, 2026

Vol.52 No.22

Drugs & Targets

EU approves Ojemda as first targeted therapy in r/r pediatric low-grade glioma regardless of BRAF alteration

The European Commission has granted conditional marketing authorization for Ojemda (tovorafenib) as monotherapy for the treatment of patients 6 months of age and older with pediatric low-grade-glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies.

April 24, 2026

Vol.52 No.16

Guest Editorial

FDA’s guidance on MRD in MM goes beyond the ODAC vote—and that’s where it matters most
Draft guidance consolidates trial design updates for developers

In January, FDA released a draft guidance entitled “Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval.” This release came roughly 20 months after the Oncologic Drugs Advisory Committee (ODAC) voted unanimously that minimal residual disease (MRD) negativity, in combination with complete response (CR), is an acceptable primary endpoint to support accelerated approval for multiple myeloma (MM) therapies.

April 03, 2026

Vol.52 No.13

By Nicholas Richardson

Drugs & Targets

FDA and EC approve Opdivo IO combinations in classical Hodgkin Lymphoma

FDA granted approval of Opdivo (nivolumab) in combination with doxorubicin, vinblastine, and dacarbazine for the treatment of adult and pediatric patients 12 years and older with previously untreated Stage 3 or 4 classical Hodgkin Lymphoma.

March 27, 2026

Vol.52 No.12

Clinical Roundup

Positive phase III results announced from the SUCCESSOR-2 study of oral mezigdomide in r/r MM

Oral mezigdomide in combination with carfilzomib and dexamethasone demonstrated statistically significant and clinically meaningful improvement in progression-free survival versus carfilzomib and dexamethasone alone in patients with relapsed or refractory multiple myeloma, according to positive interim phase III results from the SUCCESSOR-2 study.

March 13, 2026

Vol.52 No.10

EC approves Lynozyfic for treatment of r/r multiple myeloma

YOU MAY BE INTERESTED IN

Teclistamab improves outcomes in relapsed MM, phase III trial finds

European Commission authorizes expanded label for Venclyxto to include additional combinations in previously untreated CLL

EU approves Ojemda as first targeted therapy in r/r pediatric low-grade glioma regardless of BRAF alteration

FDA’s guidance on MRD in MM goes beyond the ODAC vote—and that’s where it matters most
Draft guidance consolidates trial design updates for developers

FDA and EC approve Opdivo IO combinations in classical Hodgkin Lymphoma

Positive phase III results announced from the SUCCESSOR-2 study of oral mezigdomide in r/r MM

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EC approves Lynozyfic for treatment of r/r multiple myeloma

YOU MAY BE INTERESTED IN

Teclistamab improves outcomes in relapsed MM, phase III trial finds

European Commission authorizes expanded label for Venclyxto to include additional combinations in previously untreated CLL

EU approves Ojemda as first targeted therapy in r/r pediatric low-grade glioma regardless of BRAF alteration

FDA’s guidance on MRD in MM goes beyond the ODAC vote—and that’s where it matters mostDraft guidance consolidates trial design updates for developers

FDA and EC approve Opdivo IO combinations in classical Hodgkin Lymphoma

Positive phase III results announced from the SUCCESSOR-2 study of oral mezigdomide in r/r MM

Never miss an issue!

Login

FDA’s guidance on MRD in MM goes beyond the ODAC vote—and that’s where it matters most
Draft guidance consolidates trial design updates for developers