FDA Approves New Sub-q Combo Tx for Multiple Myeloma

Earlier this month the FDA approved a ‘new’ combination therapy, Darzalex Faspro (daratumumab and hyaluronidase-fihj), from Janssen Biotech. Darzalex was originally approved in 2015 with an indication for multiple myeloma. The combo therapy is ‘new and improved’ for the same indication.

Darzalex Faspro is a subcutaneous combination injection (over 5 minutes) and is used together with bortezomib, melphalan, and prednisone to treat newly diagnosed multiple myeloma (a type of bone marrow cancer) in patients who cannot receive autologous stem cell transplant (transplant that uses their own stem cells).

Dosing Schedule:
Once weekly Weeks 1-8, Once every 2 weeks from Weeks 9 to 24, Once every 4 weeks starting with Week 25 — until disease progression or unacceptable toxicity (see prescribing information for full details).

The standard dose schedule requires 23 doses over the first 52 weeks on therapy. Published price for the 15ml dose is $8296. The annual cost tips in at $190,800.

The ‘improved’ formulation is a lot more expensive than the early version Darzalex as well as its leading competitors, Pomalyst at$147,000 and Kyprolis at $114,000 per year.

Janssen did not announce details for distribution. Patients may be burdened with frequent office visits in the early stage of therapy, but that shifts to once monthly after the first nine weeks. As such, it is likely that patients will receive therapy in the office vs. home injection. That will diminish the need for a specialty pharmacy distribution model, but Janssen is very prone to SP limited distribution. Time will tell.

FDA approves daratumumab and hyaluronidase-fihj with pomalidomide and dexamethasone for multiple myeloma

On July 9, 2021, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor.

Efficacy was evaluated in APOLLO (NCT03180736), an open-label, active-controlled trial with 304 patients randomized (1:1) to Darzalex Faspro with pomalidomide and dexamethasone (Pd) vs Pd alone.

The main efficacy outcome measure was progression-free survival (PFS). The median PFS was 12.4 months in the Darzalex Faspro-Pd treatment group and 6.9 months in the Pd treatment group (HR 0.63; 95% CI: 0.47, 0.85; p=0.0018), representing a 37% reduction in the risk of disease progression or death for patients treated with Darzalex Faspro-Pd versus Pd.

The most common adverse reactions (≥20%) in patients with multiple myeloma who received Darzalex Faspro-Pd are fatigue, pneumonia, upper respiratory tract infection, and diarrhea.

The recommended dosage of Darzalex Faspro is 1,800 mg/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously into the abdomen over approximately 3 to 5 minutes according to the recommended schedule.

View full prescribing information for Darzalex Faspro.

The FDA approved this application 2 months ahead of the FDA goal date.


Read More

Send Us A Message

This website uses cookies to ensure you get the best experience on our website.