Hematology Today—March 30, 2026

LucidQuest

3 hours ago

This week’s Hematology update highlights regulatory progress, evolving treatment delivery models, advancing clinical pipelines, and strategic expansion across blood disorders.

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💉 Sarclisa SC on-body injector moves toward EU approval in multiple myeloma [1] [EU • 27 Mar 2026]

https://www.sanofi.com/en/media-room/press-releases/2026/2026-03-27-12-00-00-3263711
Context: Sarclisa (isatuximab; Sanofi) is already approved in the EU in multiple IV-based multiple myeloma settings, and Sanofi is seeking to extend use to a subcutaneous formulation.
Key point: CHMP adopted a positive opinion for Sarclisa SC, including on-body injector and manual injection, across the current EU indications of the IV formulation.
Implication: May influence prescriber choice and payer reviews pending full data.

🏠 DARZALEX SC cleared for self or caregiver administration in Europe [2] [EU • 27 Mar 2026]

https://www.jnj.com/innovativemedicine/emea/media-center/press-releases/johnson-johnsons-darzalex-daratumumab-becomes-the-first-oncology-injectable-approved-for-administration-by-patients-or-caregivers
Context: The label update applies across ten therapeutic indications for daratumumab SC in multiple myeloma, smouldering multiple myeloma, and AL amyloidosis.
Key point: Johnson & Johnson said DARZALEX SC can now be administered by patients or caregivers from the fifth dose, following healthcare professional assessment and training.
Implication: Could streamline initiation and adherence via remote prescribing and logistics.

🧬 C4T starts cemsidomide plus elranatamab trial in relapsed/refractory multiple myeloma [3] [US • 25 Mar 2026]

https://ir.c4therapeutics.com/news-releases/news-release-details/c4-therapeutics-announces-first-patient-dosed-phase-1b-trial
Context: The Phase 1b study is open-label and multi-center, and plans to enroll up to 54 patients with one to four prior lines of therapy.
Key point: C4 Therapeutics announced the first patient dosed in a trial of cemsidomide and dexamethasone plus elranatamab in relapsed/refractory multiple myeloma.
Implication: Signals pipeline investment and modality expansion.

🇯🇵 Eque-cel advances into Japan registrational study in earlier-line myeloma [4] [Japan • 24 Mar 2026]

https://en.iasobio.com/info.php?id=303
Context: The approved study is an international, randomized, open-label, registrational Phase III trial in patients with 1–2 prior lines who are refractory to lenalidomide.
Key point: IASO Bio said Japan’s PMDA cleared its Clinical Trial Notification for Eque-cel in second- or third-line relapsed/refractory multiple myeloma.
Implication: May influence prescriber choice and payer reviews pending full data.

🔬 Sprint links DCPS sensitivity biomarkers to AML patient selection [5] [Sweden • 27 Mar 2026]

https://sprintbioscience.com/en/press-release/?slug=sprint-bioscience-publishes-new-research-findings-that-strengthen-the-potential-of-dcps-inhibitors-in-aml
Context: The new study used samples from 24 AML patients and was published in Discover Oncology.
Key point: Sprint Bioscience reported that low FHIT may identify AML patients with stronger responses to DCPS inhibition, and that IDH2 mutations often coincided with low FHIT.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

📄 Otsuka files in Japan to move Iclusig into first-line Ph+ ALL [6] [Japan • 27 Mar 2026]

https://www.otsuka.co.jp/en/company/newsreleases/2026/20260327_1.html
Context: Iclusig (ponatinib) is already approved in Japan for CML refractory or intolerant to prior therapies, and relapsed or refractory Ph+ ALL.
Key point: Otsuka submitted a supplemental application in Japan to expand Iclusig into first-line adult Philadelphia chromosome-positive acute lymphoblastic leukemia.
Implication: May influence prescriber choice and payer reviews pending full data.

🤝 Merck buys Terns to add TERN-701 in CML [7] [US • 25 Mar 2026]

https://www.merck.com/news/merck-to-acquire-terns-pharmaceuticals-inc-expanding-its-hematology-pipeline-with-tern-701-a-novel-candidate-for-chronic-myeloid-leukemia-cml/
Context: TERN-701 is in Phase 1/2 CARDINAL for previously treated chronic-phase Philadelphia chromosome-positive CML.
Key point: Merck agreed to acquire Terns Pharmaceuticals for about $6.7 billion in equity value, adding TERN-701 to its hematology pipeline.
Implication: Signals pipeline investment and modality expansion.

🌍 Chugai wins first global approval for Lunsumio plus Polivy in LBCL [8] [Japan • 23 Mar 2026]

https://www.chugai-pharm.co.jp/english/news/detail/20260323153000_1234.html
Context: The approval is based on the global Phase III SUNMO study in transplant-ineligible relapsed or refractory large B-cell lymphoma.
Key point: Chugai obtained Japan approval for Lunsumio (mosunetuzumab) plus Polivy (polatuzumab vedotin), the first approval globally for this combination in that indication.
Implication: May influence prescriber choice and payer reviews pending full data.

📊 Karyopharm SENTRY hits spleen endpoint, misses symptom endpoint in myelofibrosis [9] [US • 24 Mar 2026]

https://investors.karyopharm.com/2026-03-24-Karyopharms-Phase-3-SENTRY-Trial-in-Myelofibrosis-Met-First-Co-Primary-Endpoint,-Demonstrating-Statistically-Significant-Improvement-in-Spleen-Volume-Reduction
Context: SENTRY is a randomized Phase 3 trial in frontline myelofibrosis, with 353 patients and co-primary endpoints of SVR35 and Abs-TSS at week 24.
Key point: Karyopharm said selinexor plus ruxolitinib met the SVR35 co-primary endpoint, but did not meet the symptom co-primary endpoint.
Implication: May influence prescriber choice and payer reviews pending full data.

🩸 HYMPAVZI moves toward EU inhibitor-label expansion in hemophilia [10] [EU • 27 Mar 2026]

https://www.pfizer.com/news/announcements/pfizers-hympavzi-receives-positive-chmp-opinion-once-weekly-treatment-adults-and
Context: The proposed expansion covers adults and adolescents aged 12 years and older, at least 35 kg, with hemophilia A or B with inhibitors.
Key point: Pfizer said CHMP adopted a positive opinion for HYMPAVZI (marstacimab) in patients with inhibitors, expanding beyond its current EU non-inhibitor use.
Implication: May influence prescriber choice and payer reviews pending full data.

🏭 Kamada adds FDA-approved plasma collection capacity in Texas [11] [US • 26 Mar 2026]

https://www.kamada.com/news/kamada-announces-fda-approval-of-its-plasma-collection-center-in-san-antonio-texas/
Context: The San Antonio site is an 11,100 square foot facility with planned annual capacity of about 50,000 liters and a structure that supports both normal source and specialty plasma.
Key point: Kamada received FDA approval for its San Antonio plasma collection center, clearing commercial sales of normal source plasma.
Implication: Access programs may expand screening, initiation, and follow-up at scale.

Why it matters

Multiple myeloma delivery models continue to shift toward lower-burden administration, with Sanofi advancing an on-body injector pathway and Johnson & Johnson enabling self or caregiver dosing in Europe. [1][2]
Earlier-line and combination development in myeloma remains active, spanning cemsidomide plus elranatamab and Eque-cel in second- or third-line disease. [3][4]
Hematology pipeline competition is expanding through both internal development and M&A, highlighted by Merck’s move for TERN-701 in CML. [7]
Late-stage datasets remain mixed, as Karyopharm’s SENTRY showed a clear spleen benefit without a symptom win on the second co-primary endpoint. [9]
Blood disorder news extended beyond oncology this week, with HYMPAVZI’s inhibitor expansion path and Kamada’s plasma infrastructure build-out. [10][11]

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FAQ

What changed for Sarclisa in Europe this week?

Sanofi said CHMP adopted a positive opinion for Sarclisa SC across the current EU IV indications in multiple myeloma. The submission includes on-body injector and manual injection options, with support from IRAKLIA and other studies. [1]

How is the DARZALEX update different from the Sarclisa update?

DARZALEX SC received an approved label update that allows self or caregiver administration from the fifth dose after training. Sarclisa is still at the CHMP positive-opinion stage for a new SC delivery option. [1][2]

What does C4 Therapeutics actually report here?

C4T reported a trial-start milestone, not efficacy data. The company said the first patient was dosed in a Phase 1b study of cemsidomide, dexamethasone, and elranatamab in relapsed/refractory multiple myeloma. [3]

Why is the Eque-cel Japan update notable?

IASO Bio said PMDA cleared a registrational Phase III study in second- or third-line relapsed/refractory multiple myeloma. That extends the program in Japan beyond the company’s prior late-line development path. [4]

What is the practical read-through from Karyopharm’s SENTRY result?

Selinexor plus ruxolitinib improved SVR35 versus ruxolitinib alone, but missed the symptom co-primary endpoint. Karyopharm said it plans to discuss the totality of the data with FDA. [9]

Why does Merck want TERN-701?

TERN-701 is an investigational oral allosteric BCR::ABL1 inhibitor in Phase 1/2 for previously treated CML. Merck framed the acquisition as a way to expand its hematology pipeline and diversify its oncology portfolio. [7]

Entities / Keywords

Sarclisa, isatuximab, DARZALEX, daratumumab, cemsidomide, elranatamab, ELREXFIO, Eque-cel, equecabtagene autoleucel, CAR-T, multiple myeloma, relapsed/refractory multiple myeloma, AML, acute myeloid leukemia, DCPS inhibitor, FHIT, IDH2, Iclusig, ponatinib, Ph+ ALL, TERN-701, chronic myeloid leukemia, CML, Lunsumio, mosunetuzumab, Polivy, polatuzumab vedotin, large B-cell lymphoma, LBCL, selinexor, ruxolitinib, myelofibrosis, HYMPAVZI, marstacimab, hemophilia A, hemophilia B, inhibitors, plasma collection, Kamada