Onco-Summaries: Daily Oncology Updates at a Glance

17/03/2026

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• CRISM Therapeutics' irinotecan received the FDA ODD for malignant glioma

• Voro Therapeutics and Daiichi Sankyo sign a research collaboration for Next-Generation Tumor-Activated ADCs

• Myriad Genetics' MyChoice CDx test received FDA approval as the companion diagnostic for Zejula

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CRISM Therapeutics' irinotecan received the FDA ODD for malignant glioma (Ref)

The US FDA granted the Orphan Drug Designation to CRISM Therapeutics Corporation's irinotecan for the treatment of malignant glioma.

• Chris McConville, Chief Scientific Officer, CRISM Therapeutics: "Receiving Orphan Drug Designation from the FDA is a strong validation of the potential of irinotecan-ChemoSeed. From a strategic perspective, this designation enhances the regulatory profile and potential commercial attractiveness of the programme and supports our strategy of advancing differentiated oncology assets that address significant unmet medical needs.

  
  

  • When combined with our Innovation Passport and participation in the UK's ILAP programme, we believe irinotecan-ChemoSeed is well positioned for constructive regulatory engagement as we progress with our registration-grade Phase 2 clinical trial of Irinotecan ChemoSeed in surgically resectable glioblastoma.''  

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Voro Therapeutics and Daiichi Sankyo sign a research collaboration for Next-Generation Tumor-Activated ADCs (Ref)

Voro Therapeutics signed a research collaboration with Daiichi Sankyo through its Daiichi Sankyo Research Institute San Diego.

• Under the agreement, Voro Therapeutics will apply its PrimeBody masking and linker technologies to design and characterize masked ADC candidates directed against a selected oncology target

• The collaboration will leverage Voro's previous experience and demonstrated success in creating tumor-activated biologics, including its lead CD47 blocker program, which has shown improved therapeutic index in preclinical studies.

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Myriad Genetics' MyChoice CDx test received FDA approval as the companion diagnostic for Zejula (Ref)

The US FDA granted approval to Myriad Genetics' MyChoice® CDx Test as the Companion Diagnostic (CDx) for GSK's Zejula® (niraparib; PARP inhibitor) for patients with advanced ovarian cancer.

• This approval is based on final data from the PRIMA trial, where the MyChoice CDx Test determined homologous recombination deficiency (HRD) status and was used to stratify advanced ovarian cancer patients.

• Brian Donnelly, Chief Commercial Officer, Myriad Genetics: “The FDA approval reinforces Myriad’s long-standing leadership in ovarian cancer diagnostics and underscores the clinical importance of comprehensive HRD testing. By enabling precise identification of patients who may benefit from PARP inhibitors, MyChoice CDx helps ensure that treatment decisions are guided by robust genomic insights.”

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