A Look Back at FDA News From December 2022

In December 2022, the FDA granted 5 approvals, including olutasidenib (Rezlidhia) and olutasidenib capsules for acute myeloid leukemia (AML), adagrasib (Krazati) for KRAS G12C–mutated non–small cell lung cancer (NSCLC), nadofaragene firadenovec-vncg (Adstiladrin) for high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC), and mosunetuzumab-axgb (Lunsumio) for follicular lymphoma.

The FDA also granted 2 breakthrough therapy designations, 1 fast track designation, accepted for priority review supplemental biologics license applications, lifted a clinical hold, and cleared an investigational new drug application across multiple fields.

A biologics license application was submitted to the FDA for talquetamab for patients with relapsed or refractory multiple myeloma. Also in the myeloma space, the FDA requested a withdrawal of the United States marketing authorization for melphalan flufenamide for patients with multiple myeloma.

Then in late December, FDA decided they were unable to grant approval to toripalimab in combination with gemcitabine and cisplatin in the first-line for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (NPC), as well as for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.

Here is a look back at the FDA happenings of December 2022.

FDA Considers BLA for I/ONTAK for the Treatment of Persistent or Recurrent CTCL

On December 1, 2022, the FDA accepted the biologics license application for denileukin diftitox (I/ONTAK; E777), a potential treatment option of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL). The FDA plans to decide on the BLA by September 28, 2022.

FDA Grants FTD to Pelareorep Plus Atezolizumab and Chemotherapy for Advanced PDAC

Also on December 1, 2022, the FDA granted fast track designation to the combination of pelareorep (Reolysin) and atezolizumab (Tecentriq) with gemcitabine and nab-paclitaxel, for the treatment of patients with advanced or metastatic PDAC.

FDA Approves Olutasidenib for Relapsed/Refractory IDH1+ Acute Myeloid Leukemia

On December 2, 2022, the FDA granted approval to olutasidenib (Rezlidhia) capsules for the treatment of adult patients with relapsed or refractory AML with a susceptible IDH1 mutation, as detected by an FDA-approved test.

FDA Clears IND for BEAM-201 in Relapsed/Refractory T-ALL/T-LL

The FDA also lifted the clinical hold and cleared the investigational new drug (IND) application for BEAM-201 on December 2, 2022, for patients with relapsed/refractory T-ALL/T-LL.

FDA Grants Breakthrough Therapy Designation to SNDX-5613 for R/R KMT2Ar Acute Leukemia

On December 5, 2022, the FDA has granted a breakthrough therapy designation to SNDX-5613 (revumenib) for the treatment of adult and pediatric patients with relapsed or refractory acute leukemia harboring a KMT2A rearrangement.

FDA Requests Withdrawal of Melphalan Flufenamide for R/R Multiple Myeloma

The FDA requested a withdrawal of the United States marketing authorization for melphalan flufenamide (Pepaxto) for patients with relapsed or refractory multiple myeloma on December 7, 2022.

FDA Approves Adagrasib for KRAS G12C-Mutant Locally Advanced/Metastatic NSCLC

On December 12, 2022, the FDA granted accelerated approval to adagrasib (Krazati) for the treatment of adult patients with KRAS G12C–mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least 1 prior systemic therapy.

FDA Approval Sought for Talquetamab for the Treatment of R/R Multiple Myeloma

A biologics license application was submitted to the FDA on December 9, 2022, for talquetamab for the treatment of patients with relapsed or refractory multiple myeloma.

FDA Approves Nadofaragene Firadenovec-vncg for BCG-Unresponsive NMIBC

The FDA granted approval to nadofaragene firadenovec-vncg (Adstiladrin) for the treatment of adult patients with high-risk BCG-unresponsive NMIBC with carcinoma in situ with or without papillary tumors on December 16, 2022.

FDA Accepts sBLAs for Enfortumab Vedotin and Pembrolizumab in Locally Advanced or Metastatic UC

On December 20, 2022, the FDA accepted for priority review supplemental biologics license applications for the combination of enfortumab vedotin-ejfv (Padcev) and pembrolizumab (Keytruda) in patients with locally advanced or metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy.

FDA Approves Olutasidenib in Relapsed/Refractory AML

The FDA granted approval to olutasidenib (Rezlidhia) for the treatment of patients with treatment-naïve and relapsed or refractory acute myeloid leukemia, on December 21, 2022.

FDA Grants Breakthrough Therapy Designation to Adagrasib Plus Cetuximab for KRAS G12C+ Advanced CRC

On December 22, 2022, the FDA granted breakthrough therapy designation to adagrasib (Krazatitm) in combination with cetuximab (Erbitux) for the treatment of patients with KRAS G12C-mutated advanced colorectal cancer (CRC) whose cancer has progressed following prior treatment with chemotherapy and an anti-VEGF therapy.

FDA Approves Mosunetuzumab-axgb for Relapsed/Refractory Follicular Lymphoma

The FDA granted approval to mosunetuzumab-axgb (Lunsumio) on December 23, 2022, for the treatment of adult patients with relapsed or refractory follicular lymphoma after 2 or more lines of systemic therapy.

FDA Decision on Toripalimab for Advanced Nasopharyngeal Carcinoma Pending Due COVID-19 Travel Restrictions

The FDA was unable to grant approval to toripalimab in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic NPC and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy on its Prescription Drug User Fee act action date of December 23, 2022.

ZB131 Receives FDA Orphan Drug Status for Pancreatic Cancer Treatment

On December 24, 2022, the FDA granted orphan drug designation to ZB131 for the treatment of patients with pancreatic cancer.