Johnson and Johnson Gets CDSCO Panel Nod For Additional Indication of Daratumumab to Treat Light chain AL amyloidosis

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-05-25T18:00:03+05:30 | Updated On 25 May 2024 6:00 PM IST

New Delhi: Granting local clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved Johnson and Johnson's anticancer drug Daratumumab solution for Injection 1800 mg (120 mg/ml) for an additional indication for the treatment of Light chain (AL) amyloidosis in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic AL amyloidosis.

This came after Johnson and Johnson presented the proposal for approval of additional indication i.e, for the treatment of Light chain (AL) amyloidosis in combination with cyclophosphamide, bortezomib, and dexamethasone for the treatment of adult patients with newly diagnosed systemic AL amyloidosis along with a request for local clinical trial waiver.

The committee noted that the treatment of Light chain (AL) amyloidosis comes under the orphan drug category, and the applied indication is approved in the US, EU, Canada, Brazil, Switzerland, the U.K., and China.

Amyloidosis is a disorder of protein misfolding and metabolism in which insoluble fibrils are deposited in various tissues, causing organ dysfunction and eventually death.

Primary or light chain (AL) amyloidosis, the most common type of systemic amyloidosis, occurs when the free light chains normally associated with immunoglobulins are produced in excess by clonal or frankly malignant plasma cells. Although AL amyloidosis is not considered a cancer, it shares some similar characteristics and treatments with multiple myeloma.

Daratumumab is a CD38-directed cytolytic antibody used alone or as an adjunct drug in the treatment of multiple myeloma and light chain amyloidosis. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found in some types of immune cells and tumor cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill tumor cells.

Daratumumab binds to CD38, causing cells to apoptosis via antibody-dependent cellular cytotoxicity, complement-dependent cytotoxicity, inhibition of mitochondrial transfer, or antibody-dependent cellular phagocytosis.

At the recent SEC meeting held for Oncology on 15th May 2024, the expert panel reviewed the proposal presented by Johnson and Johnson for approval of additional indication of Daratumumab solution for Injection 1800 mg (120 mg/ml) for the treatment of Light chain (AL) amyloidosis in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic AL amyloidosis along with a request for local clinical trial waiver.

The committee observed that the treatment of Light chain (AL) amyloidosis comes under the orphan drug category. Furthermore, the expert panel highlighted that the applied indication for the treatment of Light Chain (AL) Amyloidosis is approved in the US, EU, Canada, Brazil, Switzerland, the UK, and China.

After detailed deliberation, the committee recommended approval of the proposed additional indication with a waiver of a local clinical trial with the condition to conduct the Phase IV clinical trial.

Accordingly, the expert panel suggested that the firm should submit the Phase IV clinical trial protocol to CDSCO within 3 months for SEC deliberation.

Also Read:Discontinue Olaparib Tablets Marketing For Specific Cancers: CDSCO

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Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751