Kristi Rosa

The FDA has granted a fast track designation to devimistat (CPI-613) for the treatment of patients with acute myeloid leukemia.

FDA approves Gallium 68 PSMA-11, the first drug for PET imaging of prostate-specific membrane antigen–positive lesions in patients with prostate cancer.

FDA grants fast track designation to irinotecan liposome injection (Onivyde; MM-398) as second-line monotherapy for patients with small cell lung cancer whose disease progressed following a platinum-based chemotherapy regimen.

Pralsetinib (Gavreto) approved for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer.

FDA grants fast track designation to the BTK inhibitor rilzabrutinib for the treatment of patients with immune thrombocytopenia.

A review of the biologics license application for lisocabtagene maraleucel in the treatment of relapsed/refractory large B-cell lymphoma following at least 2 previous therapies has been delayed.

PD-L1 IHC 22C3 pharmDx will aid in the identification of patients with triple-negative breast cancer eligible for treatment with pembrolizumab.

The FDA approved FoundationOne Liquid CDx as a companion diagnostic with olaparib for certain patients with metastatic castration-resistant prostate cancer.

FDA lift clinical hold placed on the phase 1 PSMA-101-001 study of the chimeric antigen receptor T-cell therapy P-PSMA-101 in patients with metastatic castration-resistant prostate cancer.

FDA approves the cobas EGFR Mutation Test v2 as a companion diagnostic for EGFR TKIs in the treatment of EGFR-mutated non–small cell lung cancer.

The FDA granted priority review to a supplemental biologics license application for cemiplimab-rwlc for the frontline treatment of patients with locally advanced or metastatic non–small cell lung cancer.

The FDA granted priority review to a supplemental biologics license application for trastuzumab deruxtecan in patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma.

FDA approves FoundationOne Liquid CDx as a companion diagnostic for alpelisib in advanced or metastatic breast cancer, rucaparib in advanced ovarian cancer, and alectinib in a specific type of metastatic non–small cell lung cancer.

The FDA granted osimertinib (Tagrisso) priority review designation for the adjuvant treatment of patients with early-stage EGFR-mutated non–small cell lung cancer following complete tumor resection with curative intent.

Pembrolizumab (Keytruda) has demonstrated promising activity when used in combination with chemotherapy or quavonlimab in select patients with nonsquamous non–small cell lung cancer.

Copanlisib (Aliqopa) in combination with rituximab (Rituxan) prolonged progression-free survival in patients with non-Hodgkin lymphoma who relapsed following 1 or more previous lines of rituximab-based therapy.

Pacritinib is a JAK2/FLT3 inhibitor for the treatment of patients with myelofibrosis and severe thrombocytopenia defined as platelet counts of less than 50,000 μL.

Enfortumab vedotin-ejfv (Padcev) elicited durable responses in patients with locally advanced or metastatic urothelial cancer who received previous treatment with a PD-1/PD-L1 inhibitor.

IMGN632 granted breakthrough designation for the treatment of patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm.

New drug application been submitted for TLX591-CDx (illumet), a radiopharmaceutical product that targets prostate-specific membrane antigen for the imaging of prostate cancer.

The FDA has granted fast track designation to DKN-01 for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma whose tumors have high DKK1 expression.

Adding atezolizumab (Tecentriq) to bevacizumab (Avastin) and chemotherapy failed to significantly improve progression-free survival in patients with newly diagnosed stage III/IV ovarian cancer.

Lenvatinib (Lenvima) plus pembrolizumab (Keytruda) showed early antitumor activity and tolerability in previously treated triple-negative breast cancer patients with advanced solid tumors.

The CINtec PLUS Cytology assay is indicated for women who undergo cervical cancer screening and test positive for high-risk types of human papillomavirus.

Magrolimab is a first-in-class, investigational anti-CD47 monoclonal antibody used in combination with azacitidine in treatment-naïve patients with high and very high-risk myelodysplastic syndrome,

The FDA grants fast track designation to the highly-selective N-terminal domain inhibitor EPI-7386 for the treatment of adult patients with metastatic castration-resistant prostate cancer.

The agent should be considered for frontline use as induction therapy prior to early autologous stem cell transplant, physician says.

Recently approved by the US Food and Drug Administration (FDA), the Biktarvyregimen is indicated for the treatment of adults with HIV-1 who have no history of antiretroviral therapy.

Glecaprevir/pibrentasvir found to be effective in clinical trials treating patients with hepatitis C virus also being treated for opioid substitution therapy.

None of the participants experienced grade 3 or 4 side effects.