In September 2023, the FDA granted approval to 3 agents, including motixafortide in combination with filgrastim to aid in hematopoietic stem cell mobilization in patients with multiple myeloma, momelotinib (Ojjaara) for the treatment of patients with myelofibrosis and anemia, and bosutinib for pediatric patients aged 1 year or older with chronic phase, Philadelphia chromosome-positive chronic myelogenous leukemia.

The agent also granted 3 orphan drug designations, 6 fast track designations, granted priority review to a supplemental new drug application, accepted for priority review 2 supplemental new drug applications, and acceppted a biologics license alpplication across various cancer types.

Further, the FDA extended its review of the biologics license application for lifileucel (LN-144) in advanced melanoma, confirmed plans to start a phase 3 trial of soquelitinib (formerly CPI-818) in relapsed peripheral T-cell lymphoma, and issued a complete response letter to the biologics license application seeking the approval of a biosimilar of pegfilgrastim (Neulasta) for patients with cancer.

Here is a look back at all of the FDA happenings from September 2023.

FDA Grants ODD to 3 Ingredients of INT230-6 for Soft Tissue Sarcoma

On September 7, 2023, the FDA granted an orphan drug designation to the 3 active components of INT230-6, cisplatin, vinblastine sulfate, and the diffusion enhancer SHAO-FA (8-(2-hydroxybenzoyl) amino) octanoate for the treatment of patients with soft tissue sarcoma.

FDA Gives Direction for BLA Resubmission of Denileukin Diftitox in CTCL

The FDA provided additional guidance for the planned resubmission of the biologics licence application for denileukin diftitox (Lymphir) for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma after at least 1 prior systemic therapy on September 8, 2023.

FDA Approves Aphexda to Aid in HST Mobilization in Patients With Multiple Myeloma

On September 11, 2023, the FDA granted approval to motixafortide in combination with filgrastim, a compound therapy intended to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.

Meeting With FDA Confirms Phase 3 Study of Soquelitinib in PTCL

An end-of-phase/pre-phase 3 meeting between the FDA and Corvus Pharmaceuticals, Inc. on September 11, 2023, confirmed plans to initiate a phase 3 registrational clinical trial of soquelitinib (formerly CPI-818) in relapsed peripheral T-cell lymphoma.

FDA Fast Tracks AFM13 Plus AlloNK for R/R Hodgkin Lymphoma

The FDA granted fast track designation to the combination of AFM13 with AlloNK for the potential treatment of patients with relapsed/refractory Hodgkin lymphoma on September 13, 2023.

FDA Receives Rolling NDA of Tovorafenib for Pediatric Low-Grade Glioma

On September 14, 2023, the FDA received a rolling new drug application seeking the approval of tovorafenib (DAY101) monotherapy for patients with relapsed or progressive pediatric low-grade glioma.

FDA Grants Fast Track Designation to Tulmimetostat for Endometrial Cancer Treatment

Also on September 14, 2023, the FDA granted fast track designation to the second-generation EZH1/EZH2 inhibitor, tulmimetostat (CPI-0209), for the treatment of patients with advanced, recurrent, or metastatic endometrial cancer who harbor ARID1A mutations and whose disease progressed on frontline treatment.

FDA Pushes Back Decision on Lifileucel for Advanced Melanoma Treatment

On September 15, 2023, the FDA extended its review of the biologics license application for lifileucel (LN-144), a potential treatment for patients with advanced melanoma.

FDA Approves Momelotinib for the Treatment of Myelofibrosis and Anemia

The FDA approved momelotinib (Ojjaara) for the treatment of patients with myelofibrosis and anemia, also on September 15, 2023.

FDA Okays Plans to Address Clinical Hold of the HEMO-CAR-T IND

The FDA accepted Hemogenyx Pharmaceuticals' plan to resolve the clinical hold placed on the HEMO-CAR-T investigational new drug application on September 18, 2023.

FDA to Conduct a Quick Review of sNDA for Belzutifan in Advanced RCC

The FDA granted priority review to the supplemental new drug application for belzutifan (Welireg) on September 19, 2023. The application is seeking approval of the drug for the treatment of adult patients with advanced renal cell carcinoma following treatment with immune checkpoint and anti-angiogenic agents.

FDA Grants Priority Review to Pembrolizumab/Chemoradiotherapy in Cervical Cancer

On September 20, 2023, the FDA accepted for priority review a new supplemental biologics application seeking the approval of pembrolizumab (Keytruda) in combination with external beam radiotherapy and concurrent chemotherapy, followed by brachytherapy as treatment for patients with newly diagnosed high-risk locally advanced cervical cancer.

NXC-201 Gains FDA Orphan Drug Designation for AL Amyloidosis

The FDA granted an orphan drug designation for NXC-201 (formerly HBI0101) for the treatment of amyloid light chain amyloidosis on September 21, 2023.

FDA Aids IND Application Submission for Ropidoxuridine in Glioblastoma

The FDA provided positive feedback and guidance on the protocol design and Company's chemistry, manufacturing, and controls on September 25, 2023, for ropidoxuridine, a radiation sensitizer for use in combination with radiotherapy to treat brain tumors, including glioblastoma.

FDA Grants Orphan Drug Designation to Alisertib in SCLC

Also on September 25, 2023, the FDA granted an orphan drug designation to alisertib (MLN8237) for the treatment of patients with small cell lung cancer.

FDA Issues CRL to BLA of OBI Presentation of Pegfilgrastim-cbqv

A complete response letter was issued by the FDA to the biologics license application seeking the approval of a biosimilar of pegfilgrastim (Neulasta), the on-body injector presentation of pegfilgrastim-cbqv (Udenyca OnBody), also on September 25, 2023.

FDA Okays FTD of IDE161 in BRCA1/2-Mutated Ovarian Cancer

The FDA granted a fast track designation to IDE161 for adult patients with BRCA1/2-mutated, advanced, or metastatic ovarian cancer who are platinum resistant and have received prior antiangiogenic and therapy with a PARP inhibitor.

FDA Fast Tracks MYTX-011 for Patients with NSCLC and cMET Overexpression

On September 26, 2023, the FDA granted a fast track designation to MYTX-011 for the treatment of patients with NSCLC whose tumors overexpress cMET, including those whose overexpression is low and intermediate.

ABM-1310 Lands FDA Fast Track Designation for BRAF V600E+ Glioblastoma

The FDA granted a fast track designation to ABM-1310, also on September 26, 2023, for the treatment of patients with BRAF V600E-mutated glioblastoma multiforme.

FDA Approves Bosutinib for Pediatric Patients With CP-CML

On September 27, 2023, the FDA granted approval to bosutinib for the treatment of pediatric patients aged 1 year or older with chronic phase, Philadelphia chromosome-positive chronic myelogenous leukemia that is newly diagnosed or relapsed or refractory to prior therapy.

FDA Fast Tracks IDE161 for BRCA1/2-Mutated HR+/HER2- Breast Cancer

The FDA granted a fast track designation to IDE161 for the treatment of adult patients with advanced or metastatic hormone receptor-positive, HER2-negative breast cancer with germline or somatic BRCA 1/2 mutations who have progressed following treatment with at least 1 prior line of a hormonal therapy, a CDK4/6 inhibitor therapy and a poly PARP inhibitor therapy on September 28, 2023.

FDA Grants Priority Review to BLA for Odronextamab in FL and DLBCL

The FDA granted priority review to biologics license application for odronextamab (REGN 1979), a prospective option for the treatment of adult patients with relapsed or refractory follicular lymphoma or diffuse large B-cell lymphoma who have progressed after at least 2 prior systemic therapies on September 29, 2023.