Kristi Rosa

The FDA has approved a supplemental new drug application to add overall survival (OS) and other secondary end point data from the phase 3 ARAMIS trial (NCT02200614) to the prescribing information for darolutamide (Nubeqa) for the treatment of patients with nonmetastatic prostate cancer (nmCRPC).

The FDA has granted a fast track designation to the investigational antibody-drug conjugate (ADC) ARX788 for use as a monotherapy in the treatment of patients with advanced or metastatic HER2-positive breast cancer who have previously received 1 or more HER2-targeted regimens in the metastatic setting.

The FDA has approved an investigational new drug application for berubicin for the treatment of patients with glioblastoma multiforme.

The FDA has approved ponatinib for the treatment of patients with chronic-phase chronic myeloid leukemia that is resistant or intolerant to at least 2 prior kinase inhibitors.

The FDA has approved osimertinib (Tagrisso) for use as an adjuvant treatment following tumor resection in patients with non–small cell lung cancer whose tumors harbor EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

The FDA has approved the oral gonadotropin-releasing hormone (GnRH) receptor antagonist relugolix (Orgovyx) as a treatment for patients with advanced prostate cancer.

The FDA has granted priority review to a new supplemental biologics license application for pembrolizumab in combination with platinum- and fluoropyrimidine-based chemotherapy as a first-line treatment in patients with locally advanced unresectable or metastatic esophageal and gastroesophageal junction cancer.

The FDA has approved rituximab-arrx for the treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.

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

The FDA has approved margetuximab-cmkb (Margenza) plus chemotherapy for use in adult patients with metastatic HER2-positive breast cancer who have previously received 2 or more anti-HER2 regimens, at least one of which was for metastatic disease.

The FDA has granted a priority review designation to the oral FGFR1-3 selective inhibitor infigratinib for the treatment of patients with cholangiocarcinoma.

Patients from Asian countries with hormone receptor (HR)–positive, HER2-negative breast cancer may have a higher risk of disease recurrence than those from non-Asian countries, suggesting that this population may benefit from additional adjuvant treatment with abemaciclib (Verzenio).

The FDA has granted a fast track designation and an orphan drug designation to the orally bioavailable small molecule tubulin-binding agent PTC596 for potential use in patients with leiomyosarcoma; the agent also received a rare pediatric disease designation and an orphan drug designation for potential use in patients with diffuse intrinsic pontine glioma (DIPG).

November 18, 2020 - The FDA has granted a fast track designation to the BTK inhibitor rilzabrutinib for the treatment of patients with immune thrombocytopenia.

AV-GBM-1, a personalized cancer vaccine, demonstrated an improvement in progression-free survival (PFS) in patients with newly diagnosed glioblastoma, according to data from a phase 2 trial (NCT03400917).

The oncology community has risen up as a unified front in the battle against coronavirus disease 2019 (COVID-19), launching pivotal research efforts to better understand the enemy and collecting data to develop effective therapeutics to fill the treatment arsenal.

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.