The FDA orphan drug designation qualifies the sponsor of avutometinib for tax credits for clinical trials, exemption from user fees, and potential market exclusivity.
Sabrina Serani
Sabrina Serani is the assistant managing editor for Targeted Oncology.
Articles by Sabrina Serani
The National Comprehensive Cancer Network has included ArteraAI in its clinical practice guidelines as a predictive test for localized prostate cancer.
The first-in-human study that has received FDA clearance will investigate the novel autologous Innocell vaccine in stage III/IV ovarian cancer.
In an interview with Targeted Oncology, Reshma Mahtani, DO, discussed findings from a retrospective study exploring treatment options for geriatric patients with HER2-positive breast cancer.
The novel cell therapy A2B530 is the first logic-gated cell therapy aimed at selectively killing tumor cells and protecting healthy cells in colorectal cancer.
Alex Chehrazi-Raffle, MD, discussed a real-world analysis of clinical characteristics of patients with bladder cancer receiving adjuvant nivolumab or chemotherapy.
Following the development of further safety and monitoring protocols, the IOV-LUN-202 trial can resume patient enrollment.
Hedyeh Ebrahimi, MD, discussed a novel approach to targeting metastatic renal cell carcinoma through a microbiome-mediated pathway.
Amivantamab plus carboplatin and pemetrexed is now an approved first-line treatment for patients with EGFR exon 20 insertion mutation-positive non-small cell lung cancer.
In an interview with Targeted Oncology, Reshma Mahtani, DO, discussed findings of a quality improvement initiative identifying challenges for health care professionals and patients with HER2-positive breast cancer.
Alice Bertaina, MD, discussed combining T-allo10 gene therapy with stem cell transplants for the treatment of pediatric and young adult patients with hematologic malignancies.
The natural killer cell therapy IDP-023 is being studied in a phase 1 trial for the treatment of patients with non-Hodgkin lymphoma and multiple myeloma.
Ropeginterferon alfa is now a recommended first-line treatment for patients with polycythemia vera, according to the National Comprehensive Cancer Network’s updated guidelines.
The FDA has granted a breakthrough therapy designation to BAY 2927088 for the treatment of non-small cell lung cancer harboring HER2-activating mutations.
The FDA has accepted the biologics license application of tislelizumab in combination with chemotherapy for the treatment of locally advanced or metastatic gastric or gastroesophageal cancers.
The latest developments across the fields of stem cell transplantation and cellular therapy were presented at the 2024 Tandem Meetings in San Antonio, Texas, from February 21-24, 2024.
Findings from the phase 3b OReO study showed that patients with ovarian cancer who previously received a PARP inhibitor benefitted from a rechallenge with olaparib.
Pembrolizumab shows promise in advanced endometrial cancer, cutting progression risk by up to 70%. The FDA has granted a priority review for this treatment option.
AI is seemingly everywhere, and while its applications in cancer care have increased, it still faces challenges.
The FDA has accepted the biologics license application of datopotamab deruxtecan for the treatment of nonsquamous non-small cell lung cancer.
Adding prophylactic acyclovir therapy to the treatment regimen for patients undergoing a stem cell transplant reduced the rates of chemotherapy-induced oral mucositis, a common and significant adverse effect of the treatment.
A study suggests that a novel CAR T-cell therapy could be a curative treatment for some patients with chronic lymphocytic leukemia, with 25% of responders still in remission after 6 years.
The FDA has approved the combination of osimertinib plus chemotherapy for the treatment of EGFR-mutated non-small cell lung cancer.
The FDA has approved lifileucel, a tumor infiltrating lymphocyte therapy, for the treatment of advanced melanoma.
The FDA has granted an orphan drug designation to tigilanol tiglate for the treatment of soft tissue sarcoma.
The FDA has now fully approved tepotinib for the treatment of metastatic non-small cell lung cancer.
The phase 1 study of HEMO-CAR-T in patients with acute myeloid leukemia can proceed following the lifted clinical hold.
212PB-DOTAMTATE is the first targeted alpha therapy to receive a breakthrough therapy designation in this intent-to-treat population.
The study demonstrates the potential ctDNA holds for prognosis and risk stratification in patients with early-stage endometrial cancer.
Whole-exome sequencing identified genetic mutations associated with poorly differentiated thyroid cancer, paving a new path for research in the field.