A Look Back at the FDA News from September 2021

Here is a look back FDA happenings from September 2021.

In September 2021, the FDA granted 7 approvals across 7 disease types including Waldenström macroglobulinemia, marginal zone lymphoma, non–small cell lung cancer, differentiated thyroid cancer, cervical cancer, graft versus host disease, and colorectal cancer.

Additionally, the FDA granted 2 breakthrough device designations, 2 fast track designation, and 1 priority review. A device to assist with prostate tumor detection was also approved. 

FDA Approves Zanubrutinib in Adult Waldenström Macroglobulinemia

At the beginning of the month, zanubrutinib was approved by the FDA to treat adult patients with Waldenström macroglobulinemia.

FDA Approval Sought for Toripalimab Plus Chemotherapy for Metastatic Nasopharyngeal Carcinoma Treatment

A biologics license application was submitted to the FDA on September 1 seeking approval for toripalimab in combination with 2 chemotherapy agents to treat metastatic nasopharyngeal carcinoma in the front-line setting and single-agent toripalimab to treat patients in the second-line setting.

FDA Grants Orphan Drug Status to Gavocabtagene Autoleucel for Cholangiocacinoma Treatment

Gavocabtagene autoleucel was granted orphan drug designation by the FDA on September 2 and is being investigated in other solid tumors in a phase 1/2 clinical trial.

FDA Grants New Tumor Treating Fields System Breakthrough Device Designation in Metastatic Liver Cancer

On September 9, the FDA granted a breakthrough device designation to the NovoTTF-200T System, a tumor treating fields delivery system, for the treatment of unresectable or metastatic liver cancer.

FDA Grants New Tumor Treating Fields System Breakthrough Device Designation in Metastatic Liver Cancer

The FDA granted a breakthrough device designation to the NovoTTF-200T System, a tumor treating fields delivery system, for the treatment of unresectable or metastatic liver cancer on September 9.

Tislelizumab Metastatic ESCC BLA Now Under FDA Consideration for Approval

On September 13, the FDA accepted the biologics license application for tislelizumab, an anti-PD-1 immune checkpoint inhibitor for the treatment of unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma in previously treated patients.

FDA Approves Zanubrutinib for Anti-CD20 Pretreated Marginal Zone Lymphoma

An accelerated approval was granted by the FDA on September 15 to zanubrutinib, for the treatment of marginal zone lymphoma in patients who have received 1 prior anti-CD20-based therapy.

FDA Approves Mobocertinib for EGFR Exon 20-Positive mNSCLC

The FDA granted approval to mobocertinib on September 15 for the treatment of adult patients with locally advanced or metastatic EGFR exon 20 insertion–mutant metastatic non–small cell lung cancer, as detected by an FDA-approved test, and who have received prior platinum-based chemotherapy.

FDA Approves Cabozantinib for RAI-Refractory Locally Advanced or Metastatic DTC

The FDA approved cabozantinib for the treatment of patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior vascular endothelial growth factor receptor-targeted therapy and who are radioactive iodine-refractory or ineligible on September 20.

FDA Approves Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer

On September 20, tisotumab vedotin became the first and only approved antibody-drug conjugate for the treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

FDA Approves First AI Device to Assist With Prostate Cancer Detection

On September 21, the FDA authorized the marketing of Paige Prostate, the first ratification-intelligence-based software designed to identify areas with high likelihood of cancer on images from a prostate biopsy.

FDA Approves Ruxolitinib in Chronic Graft-Versus-Host Disease

On September 22, the FDA approved ruxolitinib for the treatment of chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

Alrizomadlin Lands FDA Fast Track Designation for Melanoma

Alrizomadlin, a MDM2-p53 inhibitor was granted a fast track designation on September 22 by the FDA for the treatment of relapsed/refractory unresectable or metastatic melanoma who are relapsed or refractory to prior immune-oncologic agents.

FDA Considers Approval Application for Nivolumab Plus Ipilimumab With Chemotherapy for Unresectable Advanced ESCC

The FDA accepted a supplemental biologic application for nivolumab plus ipilimumab and chemotherapy as a potential treatment option for unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma on September 27.

FDA Grants Priority Review to Cemiplimab for Recurrent/Metastatic Cervical Cancer

The FDA has accepted and granted priority review on September 28 to the supplemental biologics license application for the PD-1 inhibitor cemiplimab-wlc for the treatment of patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy.

FDA Grants Priority Review to 177Lu-PSMA-617 in mCRPC

FDA Grants Priority Review to 177Lu-PSMA-617 in mCRPCOn Setepmber 28, Positive findings from the phase 3 VISION have led the FDA to grant priority review to 177Lu-PSMA-617 for patients with metastatic castration-resistant prostate cancer.

FDA Approves Indication of Cetuximab in Combination With Encorafenib for Metastatic Colorectal Cancer

On September 29, the FDA approved cetuximab in combination with encorafenib for the treatment of adult patients with metastatic colorectal cancer harboring a BRAF V6003 mutation, after prior therapy.

NUC-1031 Granted Fast Track Designation for Advanced Biliary Tract Cancer

NUC-1031, a drug for the first-line treatment of patients with advanced biliary tract cancer, has been granted fast track designation by the FDA on September 29.