A Look Back at the FDA News from April 2021

April 30, 2021

Here is a look back at the FDA happenings from the month of April 2021.

During April, the FDA granted approvals to 6 therapies across KRAS wild types, triple-negative breast cancer, gastric cancer, endometrial cancer, and B-cell lymphoma. Additionally, the FDA continued the approval of 4 therapies and decided to not continue the approval of 2 other therapies. One accelerated approval was also granted to a therapy for urethral cancer.

Here is a look back at the FDA happenings from the month of April 2021:

FDA Grants Breakthrough Therapy Designation for Cholangiocarcinoma Treatment Futibatinib

On April 1, the FDA has granted breakthrough therapy designation to futibatinib, a covalently binding FGFR inhibitor for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements including gene fusions.

FDA Approval Sought for Pacritinib to Treat Patients with Myelofibrosis and Severe Thrombocytopenia

A rolling submission of a new drug application has been completed for pacritinib which is seeking FDA approval as a treatment for patients with myelofibrosis who have severe thrombocytopenia on April 1.

FDA Approval Sought for Plinabulin Plus G-CSF for the Treatment of Chemotherapy-Induced Neutropenia

A new drug application has been submitted to the FDA on April 1 for the combination of plinabulin and granylocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia.

FDA Grants Breakthrough Device Designation to Pancreatic Cancer Assay for Early Detection in Patients

A proprietary noninvasive test designed to detect pancreatic cancer has been granted breakthrough device designation by the FDA for patients with new-onset diabetes on April 2.

sBLA Filed With FDA for Brexucabtagene Autoleucel in Adult ALL

On April 2, a supplemental biologics license application for brexucabtagene autoleucel for the treatment of adult patients with relapsed or refractory B-cell precursors acute lymphoblastic leukemia.

ProSense Cryoablation Device Granted Breakthrough Device Designation

The FDA has administered a breakthrough device designation to ProSense, a liquid-nitrogen based cryoablation system that allows for minimally invasive breast cancer treatment, for the treatment of T1 invasive breast cancer and/or patients not suitable for surgical alternative for breast cancer on April 5.

FDA Advises on Termination of ERC1671 Clinical Trial in Recurrent Glioblastoma

On April 7, the FDA has issued a letter to the developer of the immunotherapy vaccine, ERC1671, recommending that the phase 2 clinical trial of ERC1671 in combination with granulocyte-macrophage colony-stimulating factor, and cyclophosphamide for the treatment of glioblastoma be terminated.

FDA Approves New Dose of Cetuximab for KRAS Wild-Type, EGFR Expressing mCRC or SCCHN

The FDA has approved a higher dose of cetuximab for the treatmen of patients with KRAS wild-type, EGFR-expressing metastatic colorectal cancer or squamous cell carcinoma of the head and neck April 7.

Sacituzumab Govitecan Granted Regular FDA Approval for mTNBC

The FDA granted a regular approval to sacituzumab govitecan on April 7 for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.

FDA Grants Fast Track Designation to 1L Eftilagimod Alpha for Recurrent or Metastatic HNSCC

A fast track designation was granted by the FDA to the soluble LAG-3 protein, eftilagimod alpha for the frontline treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma on April 8.

FDA Has Granted Priority Review to Tisotumab Vedotin for Advanced Cervical Cancer

On April 9, the FDA has accepted a biologics license application and granted it a priority review for tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

FDA Okays Initiation of Endoxifen Study in Ovarian Cancer

A patient with ovarian cancer has begun treatment with oral endoxifen, an active metabolite of tamoxifen, after a Safe to Proceed Letter was granted by the FDA on April 12.

CYNK-001 Granted Orphan Drug Designation for Treatment of Malignant Gliomas

The FDA on April 13 has granted orphan drug designation to CYNK-001, a non-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer cell therapy, for the treatment of patients with malignant gliomas.

FDA Accelerates Approval of Sacituzumab Govitecan in Locally Advanced or Metastatic UC

An accelerated approval was granted by the FDA to sacituzumab govitecan for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor on April 13.

FDA Authorizes Marketing of First AI Diagnostic Device for Colon Cancer

On April 13, the FDA authorized the marking of GI Genius, the first device that uses artificial intelligence to assist in the diagnosis of colon cancer.

FDA Grants Rare Pediatric Disease Designation to WP1066 for Patients With Ependymoma

The FDA granted a rare pediatric disease designation to the novel p-STAT3 inhibitor WP1066 for the treatment of patients with the rare brain and spinal cord malignancy, ependymoma on April 14.

FDA Approves Nivolumab Plus Chemotherapy as 1L Therapy for Advanced or Metastatic Gastric Cancer

On April 16, the FDA approved nivolumab in combination with certain chemotherapies for the initial treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma on April 16.

FDA Lifts Partial Clinical Hold from Study of SBP-101 in Pancreatic Cancer

On April 16, the FDA lifted a partial clinical hold on a phase 1 clinical trial of SBP-101 in combination with the standard-of-care agents gemcitabine and nab-paclitaxel as treatment of patients with metastatic pancreatic ductal adenocarcinoma.

FDA Grants Priority Review to Enfortumab Vedotin for Urothelial Cancer

On April 19, the FDA granted priority review for 2 supplemental biologics license applications for enfortumab vedotin-ejfv for the treatment of a subset of patients with locally advanced or metastatic urothelial cancer.

FDA Grants Orphan Drug Status to Novel IRAK4 Inhibitor in AML and MDS

The FDA granted an orphan drug designation to CA-4948, a first-in-class, small-molecule inhibitor of IRAK4, for the treatment of patients with acute myeloid leukemia and myelodysplastic syndrome on April 19.

FDA Grants Breakthrough Therapy Designation to Bemarituzumab for Select FGFR2b+/HER2- Advanced Gastric and GEJ Cancers

On April 20, the FDA granted breakthrough therapy designation to bemarituzumab for the first-line treatment of patients with HER2-negative metastatic and locally advanced gastric and gastroesophageal adenocarcinoma who harbor FGFR2boverexpression or amplification.

FDA Grants RMAT Designation to Novel Allogeneic CAR T-Cell Agent in Relapsed/Refractory Multiple Myeloma

On April 21, the FDA has granted a regenerative medicine advanced therapy designation to the allogeneic chimeric antigen receptor T-cell therapy ALLO-715 for the treatment of relapsed or refractory multiple myeloma.

FDA Approves Dostarlimab for Recurrent or Advanced dMMR Endometrial Cancer

The FDA has granted accelerated approval to dostarlimab-gxly on April 22 for the treatment of adult patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with platinum-containing chemotherapy and whose cancers have a specific genetic feature known as dMMR, as determined by an FDA approved test.

FDA Grants Priority Review to SH-111 for Pediatric T-ALL

On April 23, the FDA has granted priority review to the sterile injectable therapy SH-111 for the treatment of pediatric patients with T-cell leukemia.

FDA Approves Dostarlimab CDx to Detect MMR in Endometrial Cancer

On April 23, the FDA has approved the VENTANA MMR RxDX panel, a device that determines if patients with advanced or recurrent endometrial cancer are eligible for treatment with dostarlimab-gxly monotherapy.

FDA Approves Lonca in Relapsed/Refractory DLBCL

The FDA has granted approval top loncastuximab tesirine for the treatment of relapsed or refractory diffuse large B-cell lymphoma, according to a press release from ADC Therapeutics on April 23.

FDA Takes a Stand on Accelerated Immunotherapy Approvals Without Confirmatory Benefit

On April 23, the FDA has been leading an industry-wide evaluation of accelerated approvals of oncology drugs for which the clinical benefit was not verified in confirmatory trials.

FDA Removes Clinical Hold From NL-201, Allowing Launch of Study in R/R Solid Tumors

The FDA has removed the clinical hold on the investigational new drug application of NL-201, a treatment for relapsed or refractory tumors, allowing a phase 1 clinical trial to begin on April 26.

FDA Grants Orphan Drug Designation to Novel TIL Therapy for Advanced-Stage Melanoma

The FDA has granted orphan drug designation to ITIL-168 for the treatment of stage IIB to IV melanoma, an investigational, autologous cell therapy derived from tumor-infiltrating lymphocytes on April 27.

ODAC Votes to Continue Approval of Atezolizumab/Nab-Paclitaxel for Advanced or Metastatic TNBC

On April 27 the FDA's Oncologic Drugs Advisory Committee voted 7 to 2 in favor of the continued approval of atezolizumab in combination with nab-paclitaxel for the treatment of patients with advanced or metastatic triple-negative breast cancer whose tumors are positive for PD-L1 expression.

ODAC Votes to Continue Approval of Pembrolizumab For Locally Advanced or Metastatic UC

The FDA’s Oncologic Drugs Advisory Committee voted 5 to 3 in favor of continued approval of pembrolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy on April 28.

ODAC Says Yes to Continued Approval of Atezolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic UC

The FDA’s Oncologic Drug Advisory Committee voted 10 to 1 to continue the accelerated approval of atezolizumab for the frontline treatment of patients with urothelial cancer who are ineligible for cisplatin on April 28.

FDA’s ODAC Votes Against Continuation of Pembrolizumab Third-Line Indication in Gastric/GEJ Cancer

On April 29, the FDA’s Oncologic Drugs Advisory Committee has voted 6 to 2 against the continued approval of pembrolizumab as indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 who experienced disease progression on or after 2 or more prior lines of therapy,

ODAC Unanimously Supports Continued Approval of Pembrolizumab for HCC in Sorafenib-Pretreated Patients

In an 8 to 0 vote, the FDA’s Oncologic Drug Advisory Committee opted to continue to accelerated approval of pembrolizumab for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib on April 29.

FDA Grants Priority Review to Adjuvant Nivolumab for High-Risk MIUC

On April 30, the FDA has accepted a Biologics License Application for nivolumab for the adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma and granted it Priority Review.