Jordyn Sava

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.

In an interview with Targeted Oncology, Eytan M. Stein, MD, hematologic oncologist from Memorial Sloan Kettering Cancer Center, discusses the latest treatment developments and updates within the AML space.

Priority review for a biologics license application has been granted by the FDA for tremelimumab as treatment of patients with unresectable hepatocellular carcinoma.

In a 16 to 0 vote, the FDA’s Oncologic Drugs Advisory Committee has voted yes to future approvals of PI3K inhibitors being supported by randomized data given observed toxicities in the drug class, research showing a detriment in OS, a narrow range between effective, and toxic doses.

Ann LaCasce, MD, MMSc, discussed how the landscape for patients with indolent B-cell lymphomas has changed positively over the past decade.

Valencia D. Thomas, MD, discussed managing patients with aggressive non-melanoma skin cancers with the emergence of new treatment options and technology.

Trastuzumab deruxtecan for the treatment of patients with unresectable or metastatic non–small cell lung cancer has been granted priority review by the FDA.

In an interview with Targeted Oncology, William J. Gradishar, MD, discussed the current landscape of caring for patients with advanced breast cancer.

Pashtoon M. Kasi, MD, MD, MBBS, MS, discusses the case of a 50-year-old woman with recently diagnosed, unresectable colorectal cancer.

With an increasing imbalance in overall survival, the FDA approval application for the combination of ublituximab and umbralisib for the treatment of adult patients with chronic lymphocytic leukemia and small lymphocytic lymphoma has been withdrawn.

The UKALL14 misses the primary end point of improvement in event-free survival in patients with acute lymphoblastic leukemia.

PIVOT-09 trial examining bempegaldesleukin plus nivolumab in patients with renal cell carcinoma and bladder cancer has been discontinued.

In an interview, Paul G Richardson, MD, discussed the many changes seen in the multiple myeloma space over previous years and what is expected for the future.

FDA fast track designation has been granted to cell-based immunotherapy Bria-IMT for the treatment of patients with metastatic breast cancer.

The FDA has granted orphan drug designation to toripalimab for the treatment of patients with small cell lung cancer.

Anetumab ravtansine did not show superior progression-free survival or overall survival in the second-line treatment setting for patients with mesothelin-expressing malignant pleural mesothelioma, according to results from the 15743 study.

Findings of CheckMate 816 show improved event-free survival and partial complete response and promising overall survival results with the use of neoadjuvant nivolumab in combination with chemotherapy for patients with resectable NSCLC.

Prolonged periods of radiographic and clinical improvement in children and young adults with H3K27M diffuse intrinsic pontine gliomas and spinal diffuse midline gliomas has been shown with GD2-directed chimeric antigen receptor T cells.

Matthew J. Matasar, MD, discusses the ways to improve on the combination of R-CHOP in patients with diffuse large B-Cell lymphoma.

Efficacy and toxicity of standard four dose nivolumab and ipilimumab induction therapy in melanoma to be likely driven by the first 2 doses as demonstrated in the Adaptively Dosed ImmunoTherapy Trial.

MARCH study in patients with relapsed/refractory multiple myeloma confirms the results of the STORM study and demonstrates positive overall response rates.

Results from the phase 3 I/ONTAK trial demonstrated anti-tumor activity in the treatment of persistent or recurrent CTCL

In an interview with Targeted Oncology, Viktor Grünwald, MD, discussed the newest updates and advances in RCC and what the current space looks like.

An application seeking the approval of a new indication for the combination of ibrutinib, bendamustine, and rituximab in adult patients with previously untreated mantle cell lymphoma has been submitted.