Jordyn Sava

A collaboration between Merck and Athenex, Inc. has been announced to evaluate oraxol plus pembrolizumab in certain patients with non-small cell lung cancer.

Having an antibiotic de-escalation guideline did not affect the rate of bacterial infection after antibiotic de-escalation, all cause-mortality, or hospital length of stay in patients with acute myeloid leukemia and febrile neutropenia who were clinically stable and afebrile.

Data supporting prostate-specific antigen screening shows harm-benefit tradeoff to be more favorable with complementary approaches to quantifying overdiagnosis.

Long-term follow-up results from the JAVELIN Bladder 100 study further support the standard-of-care role of avelumab as frontline maintenance in patients with urothelial carcinoma.

Investigators of the phase 1/2 IMAGINE study, evaluating MT-101 in patients with refractory or relapsed peripheral T-cell lymphoma, have dosed its first patient.

The use of single-agent odronextamab demonstrated a manageable safety profile and promising preliminary activity in heavily pretreated patients with B-cell non-Hodgkin lymphoma.

The SKYSCRAPER-01 study missed its co-primary end point of progression-free survival in patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer.

Endocrine therapy plus bevacizumab with the possibility of weekly paclitaxel reinduction signals efficacy and demonstrates a good safety profile in patients with ER-positive, HER2-negative advanced or metastatic breast cancer who have responded to induction therapy.

Breakthrough therapy designation has been granted to repotrectinib by the FDA for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer.

The phase 2 VB C-02 trial examining VB10.16 in combination with atezolizumab demonstrated positive results in patients with HPV16-positive advanced cervical cancer.

Adam Cohen, MD, discussed the recent updates and advancements in BCMA-directed therapies for multiple myeloma.

Production of lutetium Lu 177 vipivotide tetraxetan and Luthathera have been temporarily suspended due to potential quality issues identified in their manufacturing processes.

The phase 2 clinical trial of the combination therapy, GT90001 and nivolumab, for the treatment of patients with advanced hepatocellular carcinoma has dosed its first patient.

The first patient has been enrolled into the PREMIER registry for patients with all stages of cancer.

Increased risks of several solid tumors found to be associated with radioactive iodine treatment for patients with childhood and young-adulthood differentiated thyroid cancer.

The primary end point has been met in the phase 3 ADVANCE trial which evaluated the efficacy and safety of efgartigimod alfa-fcab in patients with thrombocytopenia.

The FDA has 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.

Survival rates for patients with different subtypes of early breast cancer who had a pathological complete response after de-escalated 12-week trastuzumab plus pertuzumab with or without weekly paclitaxel are promising.

Combination of ribociclib plus fulvestrant achieved a median overall survival of 67.6 months in the first-line setting for patients with postmenopausal, hormone receptor-positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer.

The FDA has granted priority review to a supplemental biologics license application for durvalumab as treatment of patients with locally advanced or metastatic biliary tract cancer.

Matthew Galsky, MD, discussed the DS8201-A-U105 trial of T-DXd plus nivolumab in patients with HER2-expressing urothelial cancer.

The first patient has been dosed in the phase 1 KN-4802 trial examining the safety, tolerability, and preliminary efficacy of KIN-3248 in adult patients with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations.

The FDA has issued a complete response letter to surufatinib for the treatment of a pancreatic and extra-pancreatic neuroendocrine tumors.

In an interview with Targeted Oncology, John Mascarenhas, MD, discussed emerging therapies in treating myelofibrosis in the frontline setting as well as for those who have received prior ruxolitinib treatment.

Here’s a look back at all the FDA happenings from April 2022.

In an interview with Targeted Oncology, Marc Ladanyi, MD, discussed pooled data of larotrectinib in patients with NTRK fusion-positive cancers and how variability in NTRK gene fusions impacts outcomes.

The FDA has accepted the resubmission of an NDA for Pedmark in pediatric patients under the age of 18 with localized, non-metastatic, solid tumors.

The FDA has granted fast track designation to CFI-400945 which has shown encouraging signs of monotherapy activity in patients with acute myeloid leukemia with adverse cytogenetics.

Breakthrough therapy designation has been granted to trastuzumab deruxtecan by the FDA for patients with unresectable or metastatic HER2-low breast cancer.

NKX101 and NKX019 showed early signs of safety and efficacy in treatment of heavily pretreated patients with acute myeloid leukemia and non-Hodgkin lymphoma.