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Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- 4 days ago
- 3 min read
17/12/2025
Incyte's Minjuvi® received the EC approval for treatment of R/R Follicular Lymphoma (Ref)
The European Commission granted approved to Incyte's tafasitamab (Minjuvi; anti-CD19) + lenalidomide + rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy.
The approval follows a positive CHMP opinion, and is based on results from the Phase 3 inMIND trial
Bill Meury, President and CEO, Incyte: "The EC approval of Minjuvi addresses a critical need, bringing a new, first-of-its-kind, chemotherapy-free option to patients in Europe with relapsed or refractory FL. Historically, FL patients have had limited treatment options in the second-line setting, and we are proud to drive this important advancement for the lymphoma community as we seek to deliver innovative medicines for patients with cancer.”
J&J's RYBREVANT FASPRO™ received the FDA approval for the treatment of EGFR-mutated NSCLC (Ref)
The US FDA granted approval to Johnson & Johnson's RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) subcutaneous therapy for patients with EGFR-mutated NSCLC.
RYBREVANT FASPRO™ has been approved across all indications of RYBREVANT® (amivantamab-vmjw; EGFR x MET BsAb)
The approval is based on results from the Phase 3 PALOMA-3 trial
Joelle Fathi, D.N.P., Chief Healthcare Delivery Officer, GO2 for Lung Cancer: "Patients now have a simple, chemotherapy-free frontline option that not only targets the disease more precisely but also significantly improves survival. With the introduction of RYBREVANT FASPRO, care becomes faster, less invasive, and more aligned with what matters most to patients: time, comfort, and dignity. This therapy reduces the physical and emotional burden of lengthy infusions, giving patients and their families the opportunity to reclaim precious moments and focus on living, rather than treatment."
pharmaand GmbH's Rubraca received the FDA full approval for the treatment of BRCA mutant mCRPC (Ref)
The US FDA granted full approval to pharmaand GmbH's Rubraca (rucaparib; PARP inhibitor) for adults with a deleterious BRCA mutation-associated metastatic castration-resistant prostate cancer (mCRPC) previously treated with an androgen receptor-directed therapy.
Previously, rucaparib was granted accelerated approval in 2020 for a similar indication
The full approval is based on results from the confirmatory Phase 3 TRITON3 trial
Perioperative pembro + enfortumab vedotin elicited significant benefit in MIBC (Ref)
The Phase 3 KEYNOTE-B15/EV-304 trial of Merck & Co./MSD's pembrolizumab (anti-PD-1) + Pfizer and Astellas' enfortumab vedotin (Nectin-4 ADC) given as neoadjuvant and adjuvant treatment demonstrated a statistically significant and clinically meaningful improvement in EFS, OS and pCR rates vs neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy.
Dr. Matthew Galsky, Lillian and Howard Stratton Professor of Medicine, director of genitourinary medical oncology, Mount Sinai Tisch Cancer Center, and KEYNOTE-B15 principal study investigator: “The persistent risk of recurrence in cis-eligible patients with muscle-invasive bladder cancer, despite recent advances, underscores the continued need for effective perioperative treatments. The strength of these data demonstrates that pembrolizumab plus enfortumab vedotin—given before and after surgery—has the potential to significantly improve survival outcomes.”
These results will be submitted for presentation at an upcoming medical congress and will be discussed with global health authorities for potential regulatory filings.
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