A Look Back at FDA News from July 2022

In July 2022, the FDA granted approval to crizotinib (Xalkori) as treatment for adult and pediatric patients aged 1 year and older with unresectable, recurrent, or refractory inflammatory ALK-positive myofibroblastic tumors, and accepted 4 biologics license applications (BLA) in the nasopharyngeal carcinoma, metastatic breast cancer, and Bacillus Calmette–Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ spaces.

Five fast track designations, 4 orphan drug designations, 2 rare pediatric disease designations, and 1 priority review were granted across various disease types, including follicular lymphoma, brain cancer, T-cell acute lymphoblastic leukemia, lymphoblastic lymphoma, NTRK fusion–positive solid tumors, recurrent or metastatic nasopharyngeal carcinoma, and other disease types.

Along with the many acceptances, the FDA removed a clinical hold from the phase 3 FLAMINGO-01 clinical trial (NCT05232916) evaluating GLSI-100 in patients with HER2/neu-positive primary breast cancer. The FDA also accepted review for the premarket approval supplement application for the Pan-cancer oncoReveal™ CDx.

Further, the FDA deferred action on the BLA for tislelizumab as a second-line treatment in esophageal squamous cell carcinoma, and a during a pre-new drug application meeting with the FDA, planned patient follow-up for patients with ROS1+ advanced non-small cell lung cancer in the TRIDENT-1 study (NCT03093116) of repotrectinib (TPX-0005) was discussed.

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

FDA Grants ODD to PBI-200 in NTRK Fusion–Positive Solid Tumors

On July 6, 2022, the FDA granted an orphan drug designation to PBI-200 for the treatment of patients with NTRK fusion–positive solid tumors, including primary and metastatic brain tumors.

FDA Accepts BLA Resubmission for Toripalimab in Advanced Nasopharyngeal Carcinoma

Also on July 6, 2022, the FDA has accepted for review the BLA resubmission for toripalimab in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (NPC) as well as for toripalimab monotherapy as second-line or later treatment of patients with recurrent or metastatic NPC after platinum-containing chemotherapy.

FDA Grants Priority Review to Mosunetuzumab for Relapsed/Refractory Follicular Lymphoma

The FDA also accepted the submission of a biologics license application for mosunetuzumab (Lunsumio) and granted it priority review for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least 2 prior systemic therapies on July 6, 2022.

FDA Grants RPDD to Paxalisib for Rare Pediatric Brain Cancer

The FDA also granted rare pediatric disease designation to paxalisib (GDC-0084) on July 6, 2022, for the treatment of patients with atypical rhabdoid or teratoid tumors (AT/RT) in rare and highly-aggressive childhood brain cancer.

FDA Grants Fast Track Designation to Abelacimab for Cancer-Associated Thrombosis

On July 11, 2022, the FDA granted fast track designation to abelacimab (formerly MAA 868), a dual-acting fully human monoclonal antibody that selectively targets Factor XI and Factor XIa with high affinity, for the treatment of thrombosis associated with cancer.

FDA Accepts BLA for [Vic-] Trastuzumab Duocarmazine as HER2+ mBC Treatment

The FDA accepted the BLA for [vic-] trastuzumab duocarmazine (SYD985) for the treatment of patients with HER2-positive unresectable locally advanced or metastatic breast cancer on July 12, 2022.

FDA Lifts Clinical Hold on Phase 3 Study of GLSI-100 in HER2/Neu+ Breast Cancer

The FDA removed the clinical hold on the phase 3 FLAMINGO-01 clinical trial which is evaluating the use of the HER2-/neu peptide GLSI-100 as treatment of patients with HER2/neu-positive primary breast cancer also on July 12, 2022.

FDA Grants Orphan Drug and Fast Track Designations to Sonodynamic Therapy in Brain Cancers

The FDA granted both an orphan drug designation and a fast track designation to a novel sonodynamic therapy platform as a potential treatment for patients with recurrent glioblastoma and other malignant gliomas on July 13, 2022.

FDA Grants Orphan Drug Designation to NT-I7 for Glioblastoma Multiforme

Also on July 13, 2022, the FDA granted an orphan drug designation to NT-I7 (efineptakin alfa; rhIL-7-hyFc; GX-I7), a novel, long-acting human interleukin (IL)-7, for the treatment of patients with glioblastoma multiforme.

FDA Defers Approval Decision for Tislelizumab in Unresectable or Metastatic ESCC

On July 14, 2022, the FDA deferred action on the biologics license application for tislelizumab as a second-line treatment for patients with unresectable or metastatic esophageal squamous cell carcinoma.

FDA Approves Crizotinib for ALK-Positive Inflammatory Myofibroblastic Tumors

Also on July 14, 2022, the FDA has granted approval to crizotinib as treatment for adult and pediatric patients aged 1 year and older with unresectable, recurrent, or refractory inflammatory ALK-positive myofibroblastic tumors.

FDA Grants Orphan Drug Designation to DSP-0390 in Brain Cancer

The FDA has granted orphan drug designation for DSP-0390, an investigational emopamil-binding protein inhibitor, for the treatment of patients with brain cancer on July 18, 2022.

FDA Grants Fast Track and Rare Pediatric Disease Designations for WU-CART-007 in T-ALL/LBL

The FDA granted fast track designation and rare pediatric disease designation for WU-CART-007, a chimeric antigen receptor T-cell therapy for the treatment of patients with relapsed or refractory T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma on July 19, 2022.

FDA Accepts Review for Pillar Bioscience’s Pan-Cancer oncoReveal™ CDx

Also on July 19, 2022, the FDA accepted the review for the premarket approval supplement application for the Pan-cancer oncoReveal™ companion diagnostic.

FDA Grants Fast Track Designation to Eltanexor for R/R Myelodysplastic Syndrome

On July 21, 2022, the FDA granted fast track designation to the development of single-agent eltanexor (KPT-8602) for the treatment of patients with relapsed or refractory intermediate, high-, or very high-risk myelodysplastic syndrome.

FDA Fast Tracks OP-1250 for HR+, HER2- Metastatic Breast Cancer Treatment

The FDA granted fast track designation to OP-1250 on July 21, 2022, for the treatment of patients with HER2-negative metastatic breast cancer (mBC) that has progressed following 1 or more lines of endocrine therapy with at least 1 line given in combination with a cyclin-dependent kinase 4/6 inhibitor.

FDA Accepts BLA for Trastuzumab Deruxtecan in HER2-Low Metastatic Breast Cancer

The FDA accepted an application for the approval of fam-trastuzumab deruxtecan-nxki (Enhertu) for the treatment of select adult patients with unresectable or metastatic HER2-low breast cancer on July 25, 2022.

Pre-NDA Meeting With FDA May Lead ROS1 NSCLC Indication for Repotrectinib

On July 27, 2022, a pre-new drug application meeting with the FDA discussed planned patient follow-up for patients with ROS1+ advanced non-small cell lung cancer in cohorts of the ongoing TRIDENT-1 study (NCT03093116) of repotrectinib (TPX-0005).

FDA Accepts BLA for N-803 in BCG-Unresponsive NMIBC Carcinoma In Situ

The FDA accepted the BLA for N-803 as a treatment for patients with BCG-unresponsive NMIBC carcinoma in situ with or without Ta or T1 disease, on July 29, 2022.