dm+d

Unassigned

New Medicines

ZynlontaRelapsed or refractory diffuse large B-cell lymphoma (DLBCL) - third-line or greater

Information

Zynlonta
New molecular entity
SOBI (Swedish Orphan Biovitrum)
ADC Therapeutics

Development and Regulatory status

Phase II Clinical Trials
Pre-registration (Filed)
Approved (Licensed)
Jul 22ADC signs a deal granting Swedish Orphan Biovitrum AB (Sobi) rights to develop and market Zynlonta in hematologic and solid tumour indications outside of the U.S., excluding greater China, Singapore, and Japan. ADC gets $55 million up front, plus $50 million if the medicine wins European approval in third-line diffuse large B-cell lymphoma [7].
Oct 21EMA validate MAA for treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) [5].
May 21Launched in the US [6].
Apr 21The FDA has approved loncastuximab tesirine for the adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified [4].
Nov 20The FDA has granted a priority review for Lonca and a decision is expected by May 2021 [3].

Category

An antibody-drug conjugate (ADC) composed of a humanized monoclonal antibody directed against human CD19 and conjugate through a linker to a potent pyrrolobenzodiazepine (PBD) dimer cytotoxin
The overall annual incidence of DLBCL in Europe is 3.8 per 100,000 but the incidence increases with age and varies considerably across Europe [1].
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) - third-line or greater
Intravenous infusion

Further information

Yes

Trial or other data

Jun 21In a PII trial (NCT03589469; n=145) Lonca showed a 48% overall response rate in DLBCL patients previously treated with a median of three systemic therapies. The complete response rate was 24% and median duration of response was 10.25 [3].
Jun 20PII study (NCT03589469) is active but no longer recruiting [2].
Aug 18Single-arm PII study to evaluate the clinical efficacy and safety of loncastuximab tesirine (ADCT-402) in patients with relapsed or refractory DLBCL starts (NCT03589469). 145 adults will be recruited in the US, Italy, Switzerland and UK. Primary outcome is overall response rate; collection of these data is due to complete May 20 [2].

Evidence based evaluations