A Look Back at FDA News from June 2022

In June 2022, the FDA granted 3 approvals, including the FoundationOne companion diagnostic (CDx) to identify patients with ROS1 fusion–positive non–small cell lung cancer (NSCLC) and NTRK fusion–positive cancers, dabrafenib (Tafinlar) plus trametinib (Mekinist) for adult and pediatric patients with unresectable or metastatic solid tumors, and lisocabtagene maraleucel (liso-cel; Breyanzi) for patients with large B-cell lymphoma (LBCL).

Along with multiple approvals, the FDA granted 2 fast track designations, 3 approvals, 3 new drug applications, 6 orphan drug designations, 1 supplemental biologics license application, and 1 breakthrough therapy designation across various disease types.

The FDA withdrew its approval for umbralisib (Ukoniq) for the treatment of marginal zone and follicular lymphoma due to safety concerns and data which suggested that the oral inhibitor of PI3K-δ and CK1-ε may be associated with an increased risk of death in patients. Additionally, the phase 1/2 NUV-422-02 trial examining NUV-422 in solid tumors was halted after some patients treated with NUV0422 developed uveitis, a form of inflammation in the eye.

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

FDA Withdraws Approvals for Umbralisib in Marginal Zone and Follicular Lymphoma

On June 2, 2022, the FDA withdrew its approval for umbralisib, which had previously been approved for marginal zone lymphoma and follicular lymphoma.

FDA Grants Fast Track Status to PDS0101 Plus Pembrolizumab for Recurrent/Metastatic HPV16+ HNSCC

Fast track designation was granted by the FDA to the combination of PDS0101 and pembrolizumab (Keytruda), an investigational regimen for the treatment of patients with recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma, also on June 2, 2022.

Omidubicel Developer Seeks FDA Approval to Treat Blood Cancers in Need of Transplantation

A rolling submission of a biologics license application was submitted to the FDA on June 3, 2022, seeking approval of omidubicel for the treatment of patients with blood cancers in need of an allogeneic hematopoietic stem cell transplant.

FDA Approves FoundationOne CDx for ROS1 Fusion–Positive NSCLC and NTRK Fusions

On June 10, 2022, the FDA granted approval to the FoundationOne CDx which will be used to identify patients with ROS1 fusion–positive NSCLC or NTRK fusion–positive cancers who may benefit from entrectinib (Rozlytrek).

FDA Accepts sBLA for Pembrolizumab in Stage IB, II, or III NSCLC

The FDA accepted a new supplemental biologics license application for pembrolizumab used to treat patients with stage IB (≥4 cm), II, or III NSCLC following complete surgical resection, on June 13, 2022.

NDA for Momelotinib Submitted to the FDA for Myelofibrosis

A new drug application has been submitted to the FDA on June 17, 2022, for the ACVR1, ALK2, JAK1 and JAK2 inhibitor, momelotinib, which is in development for the treatment of patients with myelofibrosis.

FDA Grants ODD to Paxalisib for Rare Pediatric Brain Cancer

On June 20, 2022, the FDA granted an orphan drug designation to paxalisib (GDC-0084), for the treatment of patients with atypical rhabdoid or teratoid tumors (AT/RT) in rare and aggressive childhood brain cancer.

FDA Grants Orphan Drug Designation to QXL138AM for Pancreatic Cancers

Also on June 20, 2022, the FDA granted an orphan drug designation to QXL138AM, a first in class masked immunocytokine, for the treatment of patients with pancreatic cancer.

FDA Grants Fast Track Status to Dianhydrogalactitol for Newly-Diagnosed Glioblastoma

The FDA also granted a fast track designation to dianhydrogalactitol (VAL-083) on June 20, 2022, for the treatment of patients with newly-diagnosed unmethylated glioblastoma.

FDA Clears IND Application for Novel HSF1 Inhibitor in Patients With Advanced Cancers

The FDA provided clearance to an investigational new drug application for NXP800 to be assessed as a possible treatment for patients with various advanced cancers on June 21, 2022.

FDA Grants Orphan Drug Designation to PT217 for Small Cell Lung Cancer

Also on June 21, 2022, the FDA granted an orphan drug designation to the first-in-class bispecific antibody, PT217, as a potential treatment option for patients with small cell lung cancer.

FDA Approves Dabrafenib/Trametinib Combo for BRAF V600E–Mutated Unresectable, Metastatic Solid Tumors

On June 23, 2022, the FDA granted accelerated approval to dabrafenib plus trametinib for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors who harbor a BRAF V600E mutation, have progressed after previous treatment, and who have no satisfactory alternative treatment options.

FDA Grants Orphan Drug Designation to MB-106 for Waldenstrom Macroglobulinemia Treatment

The FDA granted orphan drug designation to MB-106, for the treatment of patients with Waldenstrom macroglobulinemia, on June 23, 2022.

FDA Grants Orphan Drug Designation to VBI-1901 for Patients Treatment of Glioblastoma

VBI-1901, a bivalent gB/pp65 immunotherapeutic vaccine candidate, was also granted orphan drug designation by the FDA on June 23, 2022, for the treatment of patients with glioblastoma.

FDA Approval Sought for Elacestrant in ER+/HER2- Advanced or Metastatic Breast Cancer

A new drug application was submitted to the FDA seeking approval of elacestrant for the treatment of patients with ER-positive/HER2-negative advanced or metastatic breast cancer on June 24, 2022.

FDA Approves Liso-Cel for Second-Line Treatment of R/R LBCL

On June 25, 2022, the FDA granted approval of the CD19-directed chimeric antigen receptor (CAR) T cell therapy, lisocabtagene maraleucel for the treatment of adult patients with LBCL, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.

FDA Halts Phase 1/2 Trial Evaluating NUV-422 in Solid Tumors

A partial clinical hold was placed by the FDA on the phase 1/2 NUV-422-02 trial examining NUV-422 in solid tumors, including high grade glioma, hormone receptor–positive advanced breast cancer, and metastatic castration-resistant prostate cancer on June 28, 2022.

FDA Grants Breakthrough Therapy Designation to Talquetamab for R/R Myeloma

On June 29, 2022, the FDA granted breakthrough therapy designation to talquetamab for the treatment of adult patients with relapsed or refractory multiple myeloma, who have previously received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.

FDA Grants Orphan Drug Designation to PT886 for Pancreatic Cancer

The FDA granted orphan drug designation on June 30, 2022 to PT886, for the treatment of patients with pancreatic cancer.

FDA Warns About Possible Increased Risk of Death and Side Effects With Duvelisib
On June 30, 2022, the FDA warned that treatment with duvelisib (Copiktra) may lead to increased risk of death and serious side effects vs other medicines in patients with leukemia and lymphoma.