FDA Approves Elrexfio for Relapsed/refractory Multiple Myeloma

The FDA has granted accelerated approval to elrexfio (elranatamab-bcmm) for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.

Elrexfio is a bispecific antibody that targets BCMA on myeloma cells and CD3 on T cells, bringing them into proximity to promote myeloma cell killing. The approval is based on data from the MagnetisMM-3 trial, which demonstrated a 51% overall response rate and a median duration of response of 13.7 months.

common side effects include cytokine release syndrome, neutropenia, and infections. The FDA requires continued evaluation of elrexfio’s clinical benefit through confirmatory trials.

Neoadjuvant Pembrolizumab plus Enfortumab Vedotin Shows Promise in Muscle-Invasive Bladder Cancer

The FDA approved neoadjuvant pembrolizumab in combination with enfortumab vedotin-ejfv for the treatment of locally advanced muscle invasive bladder cancer (MIBC), according to a press release.

The approval is based on data from the EV-302/KEYNOTE-916 trial,a phase 3,open-label trial evaluating the combination regimen in patients with MIBC who were candidates for radical cystectomy with pelvic lymph node dissection and were also ineligible for or refused cisplatin-based chemotherapy.

The combination regimen demonstrated superior EFS (HR = 0.4; 95% CI, 0.28-0.57) and OS (HR = 0.5; 95% CI, 0.33-0.74) compared with surgery alone.

Median EFS was not reached (95% CI, 37.3-NR) in the treatment arm vs. 15.7 months (95% CI, 10.3-20.5) in the radical cystectomy and pelvic lymph node dissection arm. Median OS was also not reached (95% CI, NR-NR) vs.41.7 months (95% CI, 31.8-NR), respectively.

Prescribing details for pembrolizumab includes warnings and precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation and embryo-fetal toxicity.For enfortumab vedotin-ejfv, warnings and precautions include skin reactions, hyperglycemia, pneumonitis/interstitial lung disease, peripheral neuropathy, ocular disorders, infusion site extravasation and embryo-fetal toxicity.

Recommended dosing for neoadjuvant pembrolizumab is 200 mg IV every 3 weeks in combination with 1.25 mg/kg IV enfortumab vedotin-ejfv on days 1 and 8 of a 21-cycle for three cycles. The maximum amount of enfortumab vedotin-ejfv a patient should receive is 125 mg.

In the adjuvant phase, the FDA recommends enfortumab vedotin-ejfv for six additional cycles every 3 weeks in combination with 200 mg IV pembrolizumab every 3 weeks for 14 cycles or 400 mg IV pembrolizumab every 6 weeks for seven cycles.

The duration for the combination regimen is 18 weeks in the adjuvant setting and 42 weeks for the overall duration of adjuvant therapy plus pembrolizumab as a single agent. On days when both agents are administered,enfortumab vedotin-ejfv should be given first.