• During the morning session, the Committee will discuss supplemental biologics license application (sBLA) 125746.74 for CARVYKTI (ciltacabtagene autoleucel), suspension for intravenous infusion, submitted by Janssen Biotech, Inc

• During the afternoon session, the Committee will discuss sBLA 125736.218 for ABECMA (idecabtagene vicleucel), suspension for intravenous infusion, submitted by Celgene

FDA grants accelerated approval to zanubrutinib for r/r follicular lymphoma

• ORR was 69% in the ZO arm and 46% in the obinutuzumab arm (two-sided p-value, 0.0012)

• Median DOR was not reached in the ZO arm (95% CI: 25.3 months, NE) and was 14.0 months (95% CI: 9.2, 25.1) for obinutuzumab monotherapy

• Estimated DOR rate at 18 months was 69% (95% CI: 58, 78) in the ZO arm

FDA approves Pfizer’s inotuzumab ozogamicin for pediatric patients with acute lymphoblastic leukemia

• In all patients, 22/53 (42%, 95% CI: 28.1, 55.9%) achieved CR and the median duration of CR was 8.2 months (95% CI: 2.6, NE).

• MRD negativity rate in patients with CR was 21/22 [95.5% (95% CI: 77.2, 99.9)] based on flow cytometry, and 19/22 [86.4% (95% CI: 65.1, 97.1] based on RQ-PCR.

• The most common adverse reactions, including laboratory abnormalities, were thrombocytopenia, pyrexia, anemia, vomiting, infection, hemorrhage, neutropenia, nausea, leukopenia, febrile neutropenia, increased transaminases, abdominal pain, and headache.
  

FDA approves amivantamab in first-line EGFR exon 20 insertion-mutated non-small cell lung cancer indications; converts to traditional approval

• Amivantamab + carboplatin +pemetrexed showed a statistically significant improvement in PFS vs. carboplatin + pemetrexed with a HR of 0.40 (95% CI: 0.30, 0.53; p-value<0.0001). Median PFS was 11.4 months (95% CI: 9.8, 13.7) and 6.7 months (95% CI: 5.6, 7.3) in the respective arms

• FDA action converts the May 2021 2nd line accelerated approval to a full approval based on the confirmatory Phase 3 PAPILLON study

Iovance’s AMTAGVI™ (lifileucel) Receives U.S. FDA Accelerated Approval for Advanced Melanoma

• First FDA-approved T cell therapy for a solid tumor cancer and first treatment option for advanced melanoma after anti-PD-1 and targeted therapy

• Among 73 patients, 31.5% achieved an objective response RECIST 1.1); median duration of response not reached at 18.6 months follow-up (43.5% of responses had a duration greater than 12 months)

FDA converts 2021 accelerated approval of tepotinib (EMD Serono, Inc.) in MET exon 14 NSCLC

• Initial AA granted on ORR & DOR in the VISION trial (NCT02864992), a multicenter, non-randomized, open-label, multicohort study.

• The conversion to traditional approval was based on an additional 161 patients and an added 28 months of follow-up time to assess DOR

• ORR was 57% with 40% of responders having a DOR ≥12 months; among 149 previously treated patients, ORR was 45% (95% CI: 37, 53), with 36% of responders having a DOR ≥12 months.

FDA approve Ipsen's Onivyde for the first-line treatment of metastatic pancreatic adenocarcinoma

• Statistically significant improvement in OS and PFS for the NALIRIFOX arm over the Gem+NabP arm

• Median OS was 11.1 months in the NALIRIFOX arm and 9.2 months in the Gem+NabP arm [HR] 0.84, p-value 0.0403)

• Median PFS was 7.4 months in the NALIRIFOX arm and 5.6 months in the Gem+NabP arm HR 0.70]; p-value 0.0001

FDA Grants Full Approval for BALVERSA to Treat Locally Advanced or Metastatic Bladder Cancer with Select Genetic Alterations

• Statistically significant improvements in OS, PFS, and ORR were demonstrated for erdafitinib compared with chemotherapy. Median OS was 12.1 months (95% CI: 10.3, 16.4) for patients who received erdafitinib and 7.8 months (95% CI: 6.5, 11.1) for those who received chemotherapy (hazard ratio [HR] 0.64 [95% CI: 0.47, 0.88]; p-value=0.0050).

• Converts and modifies the indication of the 2019 Accelerated Approval, converting to traditional approval in 57 months.