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Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- 5 hours ago
- 2 min read
17/02/2026
Deciphera Pharmaceuticals' NDA for tirabrutinib has been accepted by the US FDA for R/R PCNSL (Ref)
The US FDA has accepted for filing the NDA under the accelerated approval pathway for Deciphera Pharmaceuticals' tirabrutinib (Bruton tyrosine kinase inhibitor) for the treatment of relapsed or refractory primary central nervous system lymphoma (R/R PCNSL).
The FDA has set a PDUFA action date of December 18, 2026
The NDA is supported by the positive results from the Phase 2 PROSPECT study
J&J's RYBREVANT FASPRO™ received FDA approval for once a month dosing schedule for EGFRm NSCLC (Ref)
The US FDA approved a new, simplified monthly dosing schedule for Johnson & Johnson's RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj).
When administered in combination with oral LAZCLUZE® (lazertinib) for the first-line treatment of EGFR-mutated advanced NSCLC, monthly dosing delivers consistent outcomes with the previously approved bi-weekly subcutaneous (SC) dosing schedule
Danny Nguyen, M.D., Assistant Clinical Professor, Department of Medical Oncology & Therapeutics Research, City of Hope, and principal investigator for the PALOMA-3 and MARIPOSA studies: “A monthly dosing schedule offers patients convenience without sacrificing efficacy. With a flexible schedule that reduces time in the clinic, patients may be able to stay on therapy longer and free up time to focus on the moments that matter most.”
BMS' NDA for iberdomide + standard treatment has been accepted by the US FDA for R/R MM (Ref)
The US FDA has accepted Bristol Myers Squibb's NDA for iberdomide (CELMoD agent) + standard treatment (daratumumab + dexamethasone - IberDd) in patients with relapsed or refractory multiple myeloma (R/R MM).
The FDA has granted a PDUFA date of August 17, 2026
The filing was based on results from a planned analysis of MRD negativity rates in the Phase 3 EXCALIBER-RRMM study
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