Here is a look back at the FDA happenings from the month of August 2022.
Nine oncologic drugs were approved by the FDA in August 2022, including acalabrutinib (Calquence), capmatinib (Tabrecta), fam-trastuzumab deruxtecan-nxki (Enhertu), ibrutinib (Imbruvica), and more.
These approvals add to the treatment paradigm of chronic lymphocytic leukemia, small lymphocytic lymphoma, mantle cell lymphoma, HER2-low breast cancer, metastatic hormone-sensitive prostate cancer, non–small cell lung cancer, endometrial cancer, diffuse large B-cell lymphoma, beta-thalassemia, myeloid/lymphoid neoplasms, chronic graft versus host disease.
The FDA also accepted and initiated 3 biologics license applications (BLA), including 1 supplemental BLA, cleared 2 investigational new drug applications, and accepted 2 new drug applications across various disease types.
While a full clinical hold on the phase 1 study of FHD-286 in relapsed and/or refractory acute myelogenous leukemia and myelodysplastic syndrome, 3 clinical holds were lifted, including on the phase 1b CYAD-101-002 trial (KEYNOTE-B79; NCT04991948), phase 1/2 TakeAim Lymphoma clinical trial (NCT03328078), and TakeAim Leukemia study (NCT04278768).
FDA Lifts Clinical Hold on KEYNOTE-B79 Trial of a Novel CAR T-Cell Agent in mCRC
On August 1, 2022, the FDA lifted the clinical hold on the phase 1b CYAD-101-002 trial evaluating the safety and clinical activity of the investigational chimeric antigen receptor (CAR T)-cell therapy CYAD-101 when given in addition to FOLFOX (leucovorin, 5-fluorouracil, and oxaliplatin) and followed by pembrolizumab (Keytruda) in patients with unresectable metastatic colorectal cancer.
FDA Grants Priority Review to Application for Omidubicel for Blood Cancers in Need of Transplant
On August 2, 2022, the FDA accepted the biologics license application (BLA) for omidubicel with priority review as treatment for patients with blood cancers in need of allogeneic hematopoietic stem cell transplant.
FDA Clears IND Application for AVB-001 in Relapsed/Refractory Ovarian Cancer
The FDA cleared the investigational new drug application for AVB-001 as treatment for patients with peritoneal malignancies with a primary focus on relapsed and refractory ovarian cancer on August 5, 2022.
FDA Approves New Tablet Form for Acalabrutinib
Also on August 5, 2022, the FDA granted approval to acalabrutinib’s (Calquence) new tablet formulation for all current indications, including adult patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, and for relapsed or refractory mantle cell lymphoma.
FDA Approves Trastuzumab Deruxtecan in HER2-Low Metastatic Breast Cancer
The FDA also approved fam-trastuzumab deruxtecan-nxk (Enhertu) for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer on August 5, 2022.
FDA Approves Darolutamide Tablets for Metastatic Hormone-Sensitive Prostate Cancer
Darolutamide (Nubeqa) tablets in combination with docetaxel were also approved on August 5, 2022, for adult patients with metastatic hormone-sensitive prostate cancer.
FDA Grants Priority Review to NDA for Elacestrant in ER+/HER2- Advanced or mBC
On August 11, 2022, the FDA accepted a new drug application for the selective estrogen receptor degrader, elacestrant, and granted it priority review for the treatment of estrogen receptor (ER)-positive, HER2-negative advanced or metastatic breast cancer.
FDA Grants Regular Approval to Capmatinib for Patients With METex14-Positive NSCLC
Also on August 11, 2022, regular FDA approval was granted to capmatinib (Tabrecta) for adult patients with metastatic non–small cell lung cancer whose tumors have a mutation leading to MET exon 14 skipping, as detected by an FDA-approved test.
FDA Grants Accelerated Approval to Trastuzumab Deruxtecan for HER2+ Metastatic NSCLC
The FDA granted accelerated approval to trastuzumab deruxtecan for the treatment of patients unresectable or metastatic non-small cell lung cancer whose tumors have activating HER2 mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy on August 12, 2022.
FDA Approves New Pembrolizumab CDx to Identify pMMR in Endometrial Cancer
The FDA also expanded approval of the VENTANA MMR RxDx panel to help identify patients with mismatch repair–deficient solid tumors, including use as a companion diagnostic assay to determine eligibility for pembrolizumab (Keytruda) as treatment for patients with mismatch repair–proficient endometrial cancer on August 12, 2022.
FDA Grants Priority Review to Olaparib Combination for mCRPC
On August 16, 2022, the FDA granted priority review for the supplemental new drug application (sNDA) for olaparib (Lynparza) in combination with abiraterone and prednisone or prednisolone for treatment of adult patients with metastatic castration-resistant prostate cancer.
FDA Accepts sBLA for Polatuzumab Vedotin Combination in Previously Untreated DLBCL
Also on August 16, 2022, the FDA accepted a supplemental biologics license application (sBLA) for polatuzumab vedotin-piiq (Polivy) in combination with rituximab (Rituxan), cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of patients with previously untreated diffuse large B-cell lymphoma.
FDA Accepts NDA for Momelotinib in Patients With Anemia and Myelofibrosis
A new drug application (NDA) for momelotinib as a treatment option for patients with myelofibrosis and anemia was accepted by the FDA on August 17, 2022.
FDA Approves Betibeglogene Autotemcel for Beta-Thalassemia Treatment in Adults and Children
The FDA granted approval to betibeglogene autotemcel (Beti-cel; Zynteglo) also on August 17, 2022, for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions.
FDA Lifts Partial Clinical Hold on TakeAim Lymphoma Study of Emavusertib/Ibrutinib
On August 18, 2022, the FDA lifted the partial clinical hold on the phase 1/2 TakeAim Lymphoma clinical trial of emavusertib (CA-4948).
FDA Places Full Clinical Hold on Study of FHD-286 in R/R AML and MDS
The FDA placed a full clinical hold on the phase 1 study of FHD-286, an inhibitor of BRG1/BRM, in relapsed and/or refractory acute myelogenous leukemia and myelodysplastic syndrome on August 23, 2022.
FDA Approves Ibrutinib for Previously Treated Peds and Young Adults With cGVHD
On August 24, 2022, the FDA granted approval to ibrutinib (Imbruvica) for the treatment of pediatric patients ≥ 1 year of age with chronic graft versus host disease who failed 1 or more lines of systemic therapy.
Rolling BLA Initiated by FDA for Lifileucel in Patients With Advanced Melanoma
A biologics license application for lifileucel was initiated by the FDA following positive findings of the phase 2 C-144-01 trial in advanced melanoma on August 26, 2022.
FDA Approves Pemigatinib for R/R FGFR1+ Myeloid/Lymphoid Neoplasms
Also on August 26, 2022, approval was granted by the FDA to pemigatinib for the treatment of patients with myeloid/lymphoid neoplasms with FGFR1 rearrangement based on the phase 2 FIGHT-203 trial.
FDA Clears IND for CNTY-101 in Relapsed/Refractory CD19 Positive B-cell Malignancies
On August 29, 2022, an investigational new drug application was accepted by the FDA allowing for the start of a phase 1 trial to evaluate the tolerability of CNTY-101 in patients with relapsed or refractory CD19 positive B-cell malignancies.
FDA Lifts Partial Clinical Hold on the TakeAim Leukemia Study of Emavusertib
The FDA cleared the TakeAim Leukemia study to continue enrolling emavusertib (CA-4948) with or without azacytidine (Vidaza) and venetoclax (Venclexta) on August 30, 2022, in patients with acute myeloid leukemia or myelodysplastic syndrome.