Here’s a look back at all of the FDA happenings from May 2022.
By the end of May 2022, the FDA granted approval to 5 drugs or devices for patients across various cancer types, including HER2-positive metastatic breast cancer, juvenile myelomonocytic leukemia, previously untreated IDH1-mutated acute myeloid leukemia, esophageal squamous cell carcinoma, and relapsed/refractory follicular lymphoma.
The FDA also approved pegfilgrastim-pbbk (Fylnetra) with the intent to reduce the frequency of febrile neutropenia in patients with non-myeloid malignancies who are receiving myelosuppressive chemotherapy. Additionally, the FDA granted 3 orphan drug designations, 3 priority reviews, 2 breakthrough therapies, 2 fast track statuses, and 1 biologics license application.
While the FDA did not approve frontline toripalimab with or without chemotherapy for patients with advanced/metastatic nasopharyngeal carcinoma, they cleared an investigational new drug application allowing the start of the 1/2 BEXMAB study of bexmarilimab (FP-1305) plus standard of care therapy in patients with relapsed acute myeloid leukemia, myelodysplastic syndrome, or chronic myelomonocytic leukemia.
A partial clinical hold was placed on a phase 1 trial examining FHD-286 in patients with relapsed and/or refractory acute myeloid leukemia and myelodysplastic syndrome. Additionally, the FDA lifted the partial clinical hold on the phase 1 NEON-2 trial of davoceticept (ALPN-202) plus pembrolizumab (Keytruda) in adult patients with advanced solid tumors or lymphoma.
FDA Issues Complete Response Letter to Surufatinib for Advanced Neuroendocrine Tumors
On May 2, 2022, the FDA issued a complete response letter to surufatinib (previously HMPL 012) for the treatment of pancreatic and extra-pancreatic neuroendocrine tumors.
FDA Grants Orphan Drug Designation to Darovasertib for Uveal Melanoma Treatment
Also on May 2, 2022, the FDA granted orphan drug designation to darovasertib (IDE196), for the treatment of patients with uveal melanoma.
FDA Does Not Approve Frontline Toripalimab +/- Chemo for Advanced/Metastatic Nasopharyngeal Carcinoma
A complete response letter from the FDA was also issued on May 2, 2022, regarding the biologics license application for toripalimab with or without chemotherapy for the treatment of advanced recurrent or metastatic nasopharyngeal carcinoma.
FDA Grants Priority Review to Darolutamide Plus Docetaxel for mHSPC
On May 3, 2022, the FDA accepted a supplemental new drug application for darolutamide (Nubeqa) in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer and granted it priority review.
FDA Grants Breakthrough Device Designation to Precision-GI for Tumor Biopsies
The FDA granted breakthrough device designation to Precision-GI, a tool that assists with performing a tumor biopsy, on May 3, 2022.
FDA Grants Orphan Drug Designation to AB001 for Pancreatic Cancers and AML
The FDA granted orphan drug designation to AB001 on May 4, 2022, for the treatment of patients with pancreatic cancer and acute myeloid leukemia.
FDA Grants Priority Review to Durvalumab for Patients With Biliary Tract Cancer
On May 4, 2022, the FDA was granted priority review to a supplemental biologics license application for durvalumab as treatment of patients with locally advanced or metastatic biliary tract cancer.
FDA Approves Fam-Trastuzumab Deruxtecan-Nxki for Unresectable HER2+ mBC
Fam-trastuzumab deruxtecan-nxki was also approved on May 4, 2022, by the FDA for the treatment of adult patients with unresectable or HER2-positive metastatic breast cancer who have received a prior anti-HER2- based regimen.
FDA Grants Fast Track Status to HM43239 for R/R FLT3+ AML
The FDA granted a fast track designation to HM43239 for the treatment of patients with relapsed or refractory acute myeloid leukemia whose tumors harbor a FLT3 mutation on May 5, 2022.
FDA Grants Breakthrough Therapy Designation to Repotrectinib for ROS1+ Metastatic NSCLC
On May 10, 2022, breakthrough therapy designation was granted to repotrectinib (TPX-0005) by the FDA for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer.
FDA Okays Study of Bexmarilimab in Hematologic Malignancies
The FDA cleared an investigational new drug application for the start of the phase 1/2 BEXMAB study of bexmarilimab in combination with standard of care therapy in patients with relapsed acute myeloid leukemia, myelodysplastic syndrome, or chronic myelomonocytic leukemia, on May 19, 2022.
FDA Approves Azacitidine for Newly Diagnosed Juvenile Myelomonocytic Leukemia
The FDA granted approval to azacitidine (Vidaza) on May 20, 2022, for the treatment of pediatric patients with newly diagnosed juvenile myelomonocytic leukemia following positive phase 2 research.
FDA Grants XMT-2056 an Orphan Drug Designation
On May 19, 2022, the FDA granted orphan drug designation to XMT-2056, an immunosynthen STING-agonist antibody-drug conjugate (ADC), for the treatment of patients with gastric cancers.
FDA Grants Priority Review to Mirvetuximab Soravtansine in FRα-High Platinum-Resistant Ovarian Cancer
Priority review to a biologics license application was granted by the FDA for mirvetuximab soravtansine (IMGN853) to treat patients with folate receptor alpha-high platinum-resistant ovarian cancer, on May 23, 2022.
FDA Halts Study of FHD-286 in Patients With R/R AML and MDS
Also on May 23, 2022, a partial clinical hold was placed by the FDA on a phase 1 trial examining the use of FHD-286 as treatment for patients with relapsed and/or refractory acute myeloid leukemia and myelodysplastic syndrome.
BLA Submitted to the FDA for N-803 Plus BCG in BCG-Unresponsive Bladder Cancer
A biologics license application was submitted to the FDA on May 23, 2022, for N-803 (ALT-803) plus Bacillus Calmette-Guérin (BCG) as treatment for patients with BCG-unresponsive non-muscle invasive bladder cancer in situ with or without Ta or T1 disease.
FDA Lifts Partial Clinical Hold on NEON-2 Evaluating Davoceticept/Pembrolizumab in Advanced Cancers
The FDA lifted the partial clinical hold on the phase 1 NEON-2 trial of davoceticept plus pembrolizumab in adult patients with advanced solid tumors or lymphoma on May 24, 2022.
FDA Grants Fast Track Designation to Seribantumab for NRG1+ Advanced Solid Tumors
The FDA granted fast track designation to seribantumab for the treatment of advanced solid tumors that harbor NRG1 gene fusions, on May 25, 2022.
FDA Approves Ivosidenib Plus Azacitidine for Previously Untreated IDH1-Mutated AML
The FDA granted approval for ivosidenib tablets (Tibsovo) in combination with azacitidine on May 25, 2022, as treatment for patients with previously untreated IDH1-mutated acute myeloid leukemia.
FDA Approves Two Nivolumab Combinations Unresectable Advanced ESCC
On May 27, 2022, the FDA granted approval to nivolumab (Opdivo) in combination with fluoropyrimidine- and platinum-containing chemotherapy and nivolumab plus ipilimumab for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma.
FDA Approves Tisagenlecleucel for R/R Follicular Lymphoma
The FDA granted accelerated approval to tisagenlecleucel (Kymriah) for the treatment of adult patients with relapsed/refractory follicular lymphoma after receiving 2 or more lines of systemic therapy, also on May 27, 2022.
FDA Approves Fifth Pegfilgrastim Biosimilar
Also on May 27, 2022, the FDA approved pegfilgrastim-pbbk (Fylnetra), a biosimilar product referencing Neulasta.