Jordyn Sava

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for the treatment of adult patients with chronic lymphocytic leukemia and small lymphocytic lymphoma has been withdrawn.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.

Regulatory approval has been granted for Guardant360 in Japan and will offer tumor mutation profiling and companion diagnostics for therapies in patients with solid tumors which have KRAS G12C or MSI-H status.

Acclaim-2 has opened enrollment for patients with late-stage non-small cell lung cancer and will begin screening patients for their eligibility to participate in the trial.

A phase 1 trial which will evaluate the safety and efficacy of chimeric antigen receptor T-cell therapy in ovarian cancer has begun.

AZALENA trial shows encouraging response rates, duration of response and survival including patients with myelodysplastic syndrome, chronic myelomonocytic leukemia, and acute myeloid leukemia with MDS-related changes.

Use of trilaciclib prior to chemotherapy demonstrated a substantial burden of myelosuppressive hematologic adverse events within the patients with extensive-stage small-cell lung cancer.

Here's a look back at all the FDA happenings from March 2022.

Orphan drug designation has been granted to Veyonda as a form of treatment in patients with soft tissue sarcoma.

Tumor treating fields in combination with paclitaxel in patients with platinum-resistant ovarian cancer, has been recommended by an independent data monitoring committee to proceed to the final analysis based on data from the phase 3 INNOVATE-3 trial.