EP. 1: FDA Fast Tracks AVB-001 for Relapsed/Refractory Ovarian Cancer
The fast track designation for AVB-001 granted by the FDA recognizes its potential as a treatment option for patients with relapsed/refractory ovarian cancer.
EP. 2: FDA Grants Orphan Drug Designation to BDC-1001 in Gastric Cancer
Phase 2 studies are investigating BDC-1001 in HER2-positive gastroesophageal, colorectal, breast, and endometrial cancers.
EP. 3: FDA and Takeda to Withdraw Mobocertinib for EGFR Exon20+ NSCLC
The FDA and Takeda have decided to voluntarily withdraw mobocertinib, a drug for patients with EGFR exon20 insertion mutation-positive non–small cell lung cancer.
EP. 4: FG001 Gains FDA Orphan Drug Designation for High-Grade Glioma
Top-line results from a phase 2b trial evaluating FG001 for patients with high-grade glioma are expected by the end of November.
EP. 5: FDA’S ODAC Votes Yes to Eflornithine for Pediatric Neuroblastomas
The decision marks the first time the FDA has relied on a single externally controlled trial to support a potential approval in oncology.
EP. 6: FDA Grants FTD to BI 764532 in DLL3+ SCLC and Neuroendocrine Carcinoma
BI 764532 is under investigation in a first-in-human phase 1 trial for patients with extensive-stage small cell lung cancer and extrapulmonary neuroendocrine carcinoma.
EP. 7: FDA Approves Companion Diagnostic for Panitumumab in mCRC
The CRCdx RAS mutation detection kit was designed to detect 35 variants of KRAS and NRAS exon 2, 3, and 4 somatic mutations in patients with colorectal cancer.
EP. 8: FDA’s ODAC Votes No for Sotorasib in KRAS G12C-Mutated NSCLC
The FDA’s Oncologic Drug Advisory Committee met to discuss the supplemental new drug application for sotorasib for the treatment of adult patients with KRAS G12C mutated non–small cell lung cancer.
EP. 9: FDA Places Clinical Hold on IND of Lacutamab for Lymphomas
Patients who are currently benefiting from lacutamab may continue to receive the treatment while the clinical hold is in place.
EP. 10: FDA Accepts BLA Resubmission of OBI Presentation of Pegfilgrastim-cbqv
The FDA completed its inspection of a third-party filler, and no additional data or trials have been requested for resubmission.
EP. 11: FDA Approves Companion Diagnostic for Selpercatinib in RET Fusion+ Solid Tumors
The next-generation diagnostic tool is approved for companion diagnostic use with selpercatinib for select solid locally advanced and metastatic tumors.
EP. 12: FDA Grants Orphan Drug Designation to SLS009 for AML
SLS009 represents a promising solution for patients with acute myeloid leukemia, addressing a significant unmet medical need. Top-line data on the agent are expected by the end of the year.
EP. 13: FDA Greenlights Encorafenib/Binimetinib for BRAF V600E-Mutated NSCLC
Encorafenib combined with binimetinib is now an FDA-approved option for patients with BRAF V600E-mutated non-small cell lung cancer.
EP. 14: FDA Okays CDx for Encorafenib Plus Binimetinib in BRAF V600E-Mutated NSCLC
This regulatory decision follows the recent FDA approval of encorafenib plus binimetinib for adult patients with metastatic non-small cell lung cancer harboring a BRAF V600E mutation.
EP. 15: FDA Approves Adjuvant Nivolumab in Resected Stage IIB or IIC Melanoma
Positive findings from CheckMate-76K have led the FDA to approve adjuvant nivolumab monotherapy for the treatment of patients with completely resected stage IIB or IIC melanoma.
EP. 16: FDA Clears IND of TERN-701 for Chronic Myeloid Leukemia
A phase 1 trial of TERN-701 for chronic myeloid leukemia plans to start patient screening in December 2023, with initial data expected to be released in the second half of 2024.
EP. 17: FDA Approves Perioperative Pembrolizumab Plus Chemotherapy in Early NSCLC
The FDA has approved pembrolizumab in the perioperative setting for resectable stage II, IIIA, or IIIB non–small cell lung cancer.
EP. 18: DOC1021 Gains FDA Fast Track Designation in Glioblastoma Multiforme
A fast track designation has been granted to DOC1021 by the FDA for the treatment of patients with glioblastoma multiforme.
EP. 19: FDA Approves Ivosidenib for IDH1-Mutated MDS
Ivosidenib tablets have received FDA approval for the treatment of adult patients with relapsed/refractory myelodysplastic syndromes with a susceptible IDH1 mutation.
EP. 20: FDA Grants Orphan Drug Designation to TTX101 in Malignant Gliomas
TTX101 will be studied in a phase 1/2a clinical trial for patients with recurrent glioblastoma.
EP. 21: FDA Accepts IND Application of MB-109 for GBM and High-Grade Astrocytoma
Preclinical data of MB-109 from the American Association for Cancer Research Annual Meeting in 2022 support MB-109 as a potential treatment for patients with recurrent glioblastoma.
EP. 22: FDA Greenlights Toripalimab in Advanced Nasopharyngeal Carcinoma
Toripalimab in combination with gemcitabine and cisplatin, as well as toripalimab monotherapy, has been granted approval by the FDA for patients with recurrent, unresectable, or metastatic nasopharyngeal carcinoma.
EP. 23: SLS009 Earns FDA Fast Track Designation for R/R PTCL
SLS009 showed promising efficacy in a phase 1 trial and now has been granted a fast track designation by the FDA for the treatment of relapsed or refractory peripheral T-cell lymphoma.
EP. 24: FDA Grants Permission to Proceed Studies of Roginolisib Across Cancer Types
Roginolisib, a first-in-class small molecule allosteric modulator of PI3Kδ, has been given the green light by the FDA to continue studies for patients with solid and hematologic malignancies.
EP. 25: FDA Lifts Hold on Study of XMT-2056 in HER2+ Recurrent/Metastatic Solid Tumors
With the clinical hold lifted by the FDA, the phase 1 trial of XMT-2056 will continue to evaluate the agent's safety, tolerability, and efficacy in patients with HER2-expressing solid tumors.
2 Clarke Drive Cranbury, NJ 08512