For hospital pharmacy committees, oncology and haematology units, clinics and pharmacies, anti-CD38 monoclonal antibodies are among the most frequently cited biologics in multiple myeloma. This article reports what prescribing information and published trials say about this class, written for institutional buyers and clinicians. It is informational reporting, not clinical guidance.
What the Label Describes
The US prescribing information for daratumumab describes it as a CD38-directed cytolytic antibody. It is supplied as a concentrate for intravenous infusion in single-dose vials, prepared and administered by healthcare professionals, and a separate subcutaneous co-formulation with hyaluronidase is marketed in some regions. Indications in India are defined by the Indian regulator and the pack insert, and may differ from the US label. For how imported biologics compare with generics and biosimilars in Indian procurement, see our note on biosimilar versus generic medicines in India.
Trials Cited in the Literature
Published studies of daratumumab-based regimens include CASTOR and POLLUX (both N Engl J Med, 2016) in relapsed or refractory multiple myeloma, and ALCYONE (2018) and MAIA (2019) in newly diagnosed multiple myeloma. Results and conclusions below are those of the trial authors, with attribution.
- MAIA (long-term analysis): the manufacturer’s medical information summarises a median progression-free survival of 61.9 months with daratumumab plus lenalidomide and dexamethasone versus 34.4 months with lenalidomide and dexamethasone alone (HR 0.55) in transplant-ineligible newly diagnosed patients.
- PERSEUS: published in the New England Journal of Medicine, this trial in transplant-eligible newly diagnosed patients reported disease progression or death in 14.1% of the daratumumab-VRd group versus 29.1% of the VRd group at a median follow-up of 47.5 months; a later analysis at 81.3 months reported a 72-month PFS rate of 81.1% versus 56.1% (HR 0.35).
Several of the regimens named in these trials combine daratumumab with other agents such as bortezomib; related oncology lines supplied by A.K. Pharma include Velcade (bortezomib), Venclexta (venetoclax), Blincyto (blinatumomab) and Adcetris (brentuximab vedotin). These figures describe trial populations under protocol conditions. They are reported here for context and are not a recommendation for any patient or regimen.
Points Hospital Teams Often Check on the Label
- Infusion-related reactions: the prescribing information lists infusion-related reactions among its warnings; hospitals should review the label and their own infusion-unit protocols.
- Blood bank testing: the label describes interference with serological testing such as cross-matching and antibody screening, which is relevant to transfusion services.
- Storage: the pack states refrigerated storage at 2°C to 8°C in the original carton, protected from light; cold-chain handling matters for biologic stock.
Procurement Considerations for Indian Institutions
For purchase departments, the practical questions are authenticity, batch and expiry documentation, cold-chain delivery and consistent availability of both vial strengths. A.K. Pharma, a licensed pharmaceutical distributor in Delhi, supplies Darzalex (daratumumab) 100 mg/5 mL and 400 mg/20 mL in bulk and wholesale quantities to hospitals, clinics and pharmacies across India. Related oncology lines are listed under multiple myeloma medicines and the wider product range. Institutional buyers can verify credentials on the About Us page.
Related Reading
- Checkpoint inhibitors in India: what hospitals need to know
- Biosimilar vs generic medicine in India
- All cancer medicines supplied by A.K. Pharma
Sources and Further Reading
- DailyMed: daratumumab prescribing information
- N Engl J Med: PERSEUS trial
- PubMed: MAIA trial
- PubMed: CASTOR trial
- PubMed: POLLUX trial
- PubMed: ALCYONE trial
- MedlinePlus: Multiple myeloma
Bulk Supply Enquiries
Hospitals, clinics, doctors and pharmacies can contact A.K. Pharma on +91 9810034827 (call or WhatsApp) for bulk and wholesale enquiries. Single-pack orders are not supplied. You can also use the contact page to send a bulk enquiry.
Frequently Asked Questions
What do the labels say about how anti-CD38 antibodies work?
The US prescribing information for daratumumab describes it as a CD38-directed cytolytic antibody. Indian pack inserts and the national regulator define the indications applicable in India.
Which trials are usually cited for daratumumab in myeloma?
Published studies include CASTOR and POLLUX (N Engl J Med 2016) in relapsed or refractory disease, ALCYONE (2018) and MAIA (2019) in newly diagnosed disease, and PERSEUS (2024) in transplant-eligible newly diagnosed disease. Results are those of the trial authors.
Does the label mention anything relevant to hospital blood banks?
Prescribing information for daratumumab describes interference with serological testing, including cross-matching and antibody screening. Hospitals should refer to the current label and their transfusion service protocols.
Does A.K. Pharma advise on dosing or patient selection?
No. A.K. Pharma is a distributor and not a healthcare provider. Treatment decisions, including drug selection and dosing, rest solely with the treating physician.
Can hospitals and pharmacies place bulk enquiries?
Yes. A.K. Pharma supplies in bulk and wholesale quantities only to hospitals, clinics, doctors and pharmacies. Contact the team for current availability, batch and expiry details.
Disclaimer: A.K. Pharma is a licensed medicine distributor, not a healthcare provider. This article is for informational and procurement purposes only and is not medical advice. Treatment decisions, including drug selection and dosing, rest solely with the treating physician and the approved prescribing information.
