Kristi Rosa

Cancer screening has decreased since the start of the COVID-19 pandemic, but the NCCN, ACS, and other leading organizations say that it should resume.

The FDA has granted the cell-based, off-the-shelf immune primer ilixadencel an orphan drug designation for use as a treatment option in patients with soft tissue sarcoma (STS), according to an announcement from Immunicum AB.

The FDA has granted toripalimab a fast track designation for use in the frontline treatment of patients with mucosal melanoma, according to an announcement from Junshi Biosciences, the drug developer.

The FDA has granted priority review to a biologics license application (BLA) for retifanlimab (INCMGA 0012) for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who were intolerant of or who had progressed on platinum-based chemotherapy.

The FDA has granted a priority review to a supplemental biologics license application for nivolumab (Opdivo) in combination with a fluoropyrimidine- and platinum-containing chemotherapy for use in patients with advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, or esophageal adenocarcinoma.

The FDA has granted a fast track designation to padeliporfin Immune Photo Activated Cancer Therapy (ImPACT) for use in the treatment of patients with low-grade and unifocal upper-tract urothelial cancer (UTUC), according to an announcement from Steba Biotech.

The FDA has approved crizotinib (Xalkori) for the treatment of pediatric patients 1 year of age and older and young adults with ALK-positive relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL).

The addition of eganelisib (IPI-549) to nivolumab (Opdivo) was found to elicit encouraging responses and improve progression-free survival (PFS) compared with single-agent nivolumab in patients with platinum-refractory, immunotherapy-naïve, advanced, metastatic urothelial cancer, according to an update from the phase 2 MARIO-275 (NCT03980041).

The FDA has granted fast track designations to cavrotolimod (AST-008) for use in combination with a PD-1 therapy in patients with locally advanced or metastatic Merkel cell carcinoma (MCC) that is refractory to previous PD-1 blockade and for use in combination with a PD-1/PD-L1 agent in those with advanced or metastatic cutaneous squamous cell carcinoma (CSCC) that is refractory to previous PD-1/PD-L1 blockade.

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, a biosimilar to rituximab (Rituxan), for the treatment of adult patients with non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), granulomatosis with polyangiitis (GPA; Wegener's Granulomatosis), and microscopic polyangiitis (MPA).

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 (PFS) and duration of response (DOR) in patients with BRAF-mutated melanoma, suggesting potential to overcome resistance to targeted approaches, said Grant McArthur, MBBS, PhD, in a presentation during the 2020 SMR Virtual Congress.

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.