Blenrep 100mg powder for conc for soln for inf in vial available in the UK. Price for 1 vial = £5707.83 .
Approved in EU 
Approved by the FDA via the accelerated approvals pathway; indication is "for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent" . As for EMA conditional approval, further clinical data may be required for continued approval.
Recommended for EU conditional approval by CHMP - the full indication is "as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.” The medicine should be prescribed by physicians experienced in the treatment of multiple myeloma.  Conditional approval indicates that the information available is less than would usually be required, but that the medicine fulfils a significant unmet need and the benefit to risk balance is considered to be acceptable under those circumstances; the manufacturer will normally be expected to provide further clinical data to retain the marketing authorisation.
The US FDA’s Oncologic Drugs Advisory Committee (ODAC) unanimously voted, 12 to 0, to recommend belantamab mafodotin as a monotherapy for relapsed or refractory multiple myeloma in pts who have had >4 previous therapies.
In a briefing document, the FDA expressed safety concerns regarding keratopathy which affected 71% of pts in a PII study. In the PII study, of 97 pts who received the lower dose, 44% had at least one instance of severe keratopathy including many asymtpomatic cases, which makes detection difficult. No patients have lost their vision permanently. The company is working on plans to mitigate risks but the FDA briefing notes that despite implementing dose modifications, ocular toxicities were recurrent and persistent and that these side effects could limit its use.
Filed in the EU with accelerated assessment status .
Biologics License Application (BLA) submitted to US FDA for the 2.5 mg/kg dosage.
Has orphan drug status in EU & US .
FDA grants Breakthrough Therapy designation to GSK-2857916 monotherapy in patients with multiple myeloma who have failed at least three prior lines of therapy, including an anti-CD38 antibody and are refractory to a proteasome inhibitor and an immunomodulatory agent .
EMA grants PRIME designation to GSK 2857916 for treatment of relapsed and refractory multiple myeloma patients whose prior therapy included a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody .