Posted inNew Drugs

Linvoseltamab‑gcpt (Lynozyfic) was approved by FDA for Multiple Myeloma: Uses, Dosage & Cost Explained

No Comments

🌟 Approval Milestone & Official Resources

On July 2, 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval under the brand name Lynozyfic (linvoseltamab‑gcpt) for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an

immunomodulatory agent (IMiD), and an anti‑CD38 monoclonal antibody oncdata.com+14fda.gov+14pharmacytimes.com+14.

  • The FDA approval is based on results from the LINKER‑MM1 Phase 1/2 trial (clinicaltrials.gov NCT03761108).
  • In Europe, linvoseltamab received conditional marketing authorization in April 2025 and became available in the EU shortly thereafter fda.gov+10ajmc.com+10onclive.com+10.

Official Sources & Proof:


For the FDA summary, refer to “FDA grants accelerated approval to linvoseltamab‑gcpt… relapsed or refractory multiple myeloma” .
The Regeneron announcement “Lynozyfic™ (linvoseltamab‑gcpt) Receives FDA Accelerated Approval…” is another direct source oncdata.com+14newsroom.regeneron.com+14oncnursingnews.com+14.

🧬 What Is Linvoseltamab‑gcpt?

Linvoseltamab is a bispecific T‑cell engager (BiTE)—a monoclonal antibody engineered to bind two targets:

  1. BCMA (B‑cell maturation antigen) on multiple myeloma cells
  2. CD3 on T‑cells

By bridging T‑cells and cancer cells, linvoseltamab prompts T‑cell activation and destruction of malignant plasma cells onclive.com+3en.wikipedia.org+3oncnursingnews.com+3accc-cancer.org+6ajmc.com+6en.wikipedia.org+6drugs.com.

It’s the first FDA‑approved BCMA×CD3 bispecific antibody capable of flexible dosing, shifting to biweekly and even monthly administration based on patient response—thus easing treatment burden ascopost.com+8pharmacytimes.com+8drugs.com+8.

Regulatory Status:

🎯 Linvoseltamab‑gcpt: Who Is Eligible?

Linvoseltamab is intended for adult patients with relapsed or refractory multiple myeloma who have:

In the EU, the requirement is ≥3 prior therapies .

💊Linvoseltamab‑gcpt Dosing Regimen:

Clinical evidence and FDA labeling specify a meticulous dosing strategy to balance efficacy with safety:

  1. Step‑Up Phase:
  2. Weekly Dosing:
  3. Biweekly Transition:
    • From week 14 onward, 200 mg administered every 2 weeks .
  4. Monthly Maintenance:

Duration: Treatment continues until disease progression or unacceptable toxicity .

💡 Which Patients Should Receive It?

Ideal candidates:

Contraindications / Precautions:

Key Risks:

Due to these risks, linvoseltamab is only available through the Lynozyfic REMS program accc-cancer.org+14ascopost.com+14cancernetwork.com+14.

Other warnings include infections, neutropenia, hepatotoxicity, and potential embryo‑fetal toxicity drugs.com+2fda.gov+2ascopost.com+2.

📈 Efficacy Data: What the Trials Showed

From the LINKER‑MM1 trial (phase 1/2, n = 80 evaluable patients with ≥4 prior regimens):

These results underscore both the depth and durability of response—especially in heavily pre‑treated patients.

💸 What About Cost?

As a newly approved oncology biologic, linvoseltamab is expected to be high-cost, consistent with other BCMA‑targeted agents (often several hundred thousand dollars per year). However, official pricing has not yet been publicly announced.

Historical context:

  • Similar agents (e.g., CAR‑T therapies, bispecifics) typically cost $300K–$500K annually.
  • Final pricing will depend on label scope (e.g., accelerated vs confirmatory approval), insurance coverage, and negotiation outcomes.

Patient Access:

  • Most U.S. payers likely to require prior authorization.
  • Assistance programs and manufacturer support (e.g., Regeneron’s patient assistance) commonly accompany new oncology drugs.

📅 Next Steps & Ongoing Studies

✅ Summary at a Glance

FeatureSummary
Brand NameLynozyfic™
Generic Namelinvoseltamab‑gcpt
FDA ApprovalJuly 2, 2025 (accelerated) newsroom.regeneron.com+9myeloma.org+9accc-cancer.org+9
EU ApprovalApril 2025 (conditional)
IndicationR/R multiple myeloma after ≥4 prior lines (U.S.); ≥3 in EU
MechanismBCMA×CD3 bispecific T‑cell engager
DosingStep‑up → weekly → biweekly → monthly adjustments
ORR~70% (45% CR rate)
DoR89% at 9 mo; 72% at 12 mo
Key ToxicitiesCRS (46%), neurologic/ICANS (54%) — boxed warnings
AvailabilityVia REMS; requires in‑hospital monitoring during step‑up
CostNot publicly disclosed yet; expected to be in oncology biologic range
Future MilestonesConfirmatory trials, potential label expansions, global launches

💬 Final Thoughts

Linvoseltamab‑gcpt (Lynozyfic™) heralds a new era for treating relapsed/refractory multiple myeloma. Its innovative bispecific mechanism, response‑adapted dosing, and rapid, deep responses make it a valuable addition—especially for patients who have exhausted standard therapies. Yet, safety remains a key concern: cytokine release syndrome and neurotoxicity make it essential that treatment occurs in specialized centers, under the FDA’s REMS program.

For patients, the treatment offers hope—a serious option where few remain. For clinicians and payers, upcoming data and real-world use will be critical in shaping its place and accessibility.

With regulatory follow-ups and market rollout underway, linvoseltamab is positioned to become a key treatment in later-line multiple myeloma care. Stay tuned for pricing updates and future study outcomes that may expand its clinical reach.

References:

Comments

No comments yet. Why don’t you start the discussion?

Leave a Reply

Your email address will not be published. Required fields are marked *