dm+d

Unassigned

New Medicines

YgaloRelapsed or refractory multiple myeloma (MM) - in combination with dexamethasone for adults who have received at least three prior treatment regimens, including both lenalidomide and a proteasome inhibitor

Information

Ygalo
New molecular entity
Oncopeptides
Oncopeptides

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
Launched
Yes
Yes
Jul 21In the US, the FDA has issued a safety update on increased risk of death shown with melphalan flufenamide in the OCEAN trial. Oncopeptides AB were required to conduct OCEAN trial as a post-approval requirement under the Accelerated Approval program. Due to detrimental effect on overall survival, the FDA is requiring the manufacturer suspend enrolment in the trial and has also suspended enrolment in other ongoing trials with the drug [10].
Apr 21Filed in EU [6].
Mar 21Launched in US [9].
Feb 21Approved in US under Accelerated Approval program [8].
Jun 20Filed in US for use in adult patients whose disease is refractory to ≥1 proteasome inhibitor, 1 immunomodulatory agent and 1 anti-CD38 monoclonal antibody [5].
Nov 18Has orphan drug status in US [4].
Mar 15Granted orphan drug status in EU [3].

Category

Prodrug of melphalan and an alkylating peptide that stimulates caspase-3 and inhibits DNA synthesis
The incidence in Europe is 4.5-6.0 per 100,000/year with a mortality rate of 4.1 per 100,000/year [1].
Relapsed or refractory multiple myeloma (MM) - in combination with dexamethasone for adults who have received at least three prior treatment regimens, including both lenalidomide and a proteasome inhibitor
Intravenous infusion

Further information

Yes
June 2022

Trial or other data

Sep 20PIII OCEAN is ongoing but has finished recruiting; collection of primary outcome data is due to complete Mar 21 [5].
Nov 19PIII OCEAN study is recruiting; collection of primary outcome data on course to complete in Dec [4].
Nov 18Other supportive studies for the licence application include PII OP-12-M1 (NCT01897714), PII OP-106 HORIZON (NCT02963493), OP-104 ANCHOR (NCT03481556) and PII OP-107 BRIDGE [3].
Nov 18PIII OCEAN study is still recruiting [2].
Jan 17PIII OCEAN trial to investigate the efficacy and safety of melphalan flufenamide plus dexamethasone versus pomalidomide plus dexamethasone in patients with relapsed, refractory multiple myeloma who are refractory lenalidomide starts (OP-103; NCT03151811). The trial is recruiting 450 patients in the US & EU (including UK). Collection of primary outcome data due to complete Dec 19 [2].

Evidence based evaluations

YgaloRelapsed or refractory multiple myeloma (MM) - in combination with dexamethasone for adults who have received treatment with two lines of therapy, including lenalidomide

Information

Ygalo
Licence extension / variation
Oncopeptides
Oncopeptides

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Suspended
Yes
Yes

Category

Prodrug of melphalan and an alkylating peptide that stimulates caspase-3 and inhibits DNA synthesis
The incidence in Europe is 4.5-6.0 per 100,000/year with a mortality rate of 4.1 per 100,000/year [1].
Relapsed or refractory multiple myeloma (MM) - in combination with dexamethasone for adults who have received treatment with two lines of therapy, including lenalidomide
Intravenous infusion

Further information

Yes
June 2022