Kristi Rosa

The FDA has approved the FoundationOne Liquid CDx for use as a companion diagnostic with olaparib (Lynparza), which is indicated for select patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene–mutated metastatic castration-resistant prostate cancer (mCRPC).

The FDA has lifted the clinical hold placed on the phase 1 PSMA-101-001 study (NCT04249947) of the CAR T-cell therapy P-PSMA-101 in patients with metastatic castration-resistant prostate cancer.

The addition of anti–PD-1/PD-L1 to combination BRAF and MEK inhibition has been shown to improve progression-free survival and duration of response in patients with BRAF-mutated melanoma.

The FDA has granted a priority review designation to a supplemental biologics license application (sBLA) for cemiplimab-rwlc (Libtayo) for the frontline treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with a PD-L1 expression of 50% or greater.

The FDA has accepted and granted a priority review designation to a supplemental biologics license application for the antibody-drug conjugate (ADC) trastuzumab deruxtecan (Enhertu) for use in patients with HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

PLX8394, a next-generation BRAF inhibitor, in combination with cobicistat (Tybost) was found to demonstrate encouraging clinical activity with an acceptable safety profile in patients with BRAF-mutated, refractory solid tumors, according to results from a phase 1/2 trial (NCT02428712) presented during the 32nd EORTC-NCI-AACR Symposium on Molecular Targets and Therapeutics.

Afatinib (Gilotrif) was found to be effective when used in Asian and non-Asian patients with non–small cell lung cancer (NSCLC) with major uncommon and compound EGFR mutations, irrespective of ethnicity, according to results from a pooled analysis presented during the 2020 IASLC North America Conference on Lung Cancer.

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

The FDA has granted a priority review designation to a supplemental biologics license application and supplemental new drug application for nivolumab (Opdivo) plus cabozantinib (Cabometyx) for the treatment of patients with advanced renal cell carcinoma.

A rolling submission of a new drug application (NDA) for the JAK2/FLT3 inhibitor pacritinib has been initiated for patients with myelofibrosis and severe thrombocytopenia defined as platelet counts of less than 50,000 μL.

The FDA has granted an orphan drug designation and rare pediatric disease designation to the bispecific antibody nivatrotamab for the treatment of patients with neuroblastoma, according to an announcement from Y-mAbs Therapeutics, Inc.

Following preliminary review of the data submitted for the agent, the regulatory agency determined that certain portions of the Chemistry, Manufacturing, and Control (CMC) module and the Clinical module of the application require further detail. However, no non-clinical data have been requested.

A new drug application has been submitted to the FDA for TLX591-CDx, a radiopharmaceutical product that targets prostate-specific membrane antigen, for the imaging of prostate cancer through the use of positron emission tomography.

The FDA has granted a fast track designation to DKN-01 for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma whose tumors have high DKK1 expression, who have progressed on or after a fluoropyrimidine- and platinum-containing chemotherapy, and HER2/neu targeted therapy, if appropriate.

The FDA has granted a priority review to a supplemental new drug application (sNDA) for crizotinib (Xalkori) in the treatment of pediatric patients with ALK-positive relapsed/refractory systemic anaplastic large cell lymphoma (ALCL), according to an announcement from Pfizer, Inc.

The FDA has granted a breakthrough therapy designation to magrolimab for the treatment of patients with newly diagnosed myelodysplastic syndrome (MDS), according to an announcement from Gilead Sciences, Inc.

The FDA granted a 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 (mCRPC) who are resistant to standard-of-care options, according to an announcement from ESSA Pharma Inc.

The FDA has granted a breakthrough therapy designation to plinabulin for chemotherapy-induced neutropenia (CIN).

The FDA has approved copper Cu 64 dotatate injection (Detectnet) for the localization of somatostatin receptor–positive neuroendocrine tumors (NETs), according to an announcement from RadioMedix Inc. and Curium Pharma.

The FDA has issued an alert to professionals, investigators, and patients that the phase 3 IMpassion131 trial (NCT03125902) failed to show the effectiveness of atezolizumab (Tecentriq) plus paclitaxel in treatment-naïve patients with inoperable locally advanced or metastatic triple-negative breast cancer.

Blinatumomab (Blincyto) monotherapy as consolidation therapy prior to allogeneic hematopoietic stem cell transplant (HSCT) resulted a significant improvement in event-free survival (EFS) and a lower risk of recurrence in children with high-risk B-cell precursor (BCP­)–acute lymphoblastic leukemia (ALL).

The orally available belumosudil continues be promising in patients with chronic graft-versus-host disease (cGVHD) who have received 2 or more prior lines of systemic therapy

The FDA has granted a priority review to a new drug application for oral paclitaxel and encequidar for use in patients with metastatic breast cancer.

The FDA has approved CC-486 for the continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy who are not able to complete intensive curative therapy.

The FDA has approved the FoundationOne Liquid CDx, a liquid biopsy for all solid tumors with multiple companion diagnostic indications.

The FDA has approved a generic form of pemetrexed for intravenous administration as a single-agent in patients with locally advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC) that has not progressed following 4 cycles of first-line platinum-based chemotherapy.

The FDA has granted a fast track designation to paxalisib for the treatment of patients with glioblastoma.

The FDA has approved daratumumab in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received 1 or more prior lines of therapy.

The FDA’s Oncologic Drugs Advisory Committee voted in favor of approving remestemcel-L for the treatment of children with steroid-refractory acute graft-versus-host disease.

Nivolumab in combination with chemotherapy as a frontline treatment demonstrated a significant survival benefit in patients with metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma.