Kristi Rosa

November 19, 2020 - Lorlatinib has been found to significantly prolong progression-free survival, elicit a higher overall and intracranial response, and improve quality of life compared with crizotinib in treatment-naïve patients with advanced ALK-positive non­–small cell lung cancer.

November 18, 2020 - 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.

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

November 18, 2020 - The FDA has decided to lift the clinical hold placed on the phase 1 MELANI-01 trial, which is examining the CAR T-cell therapy UCARTCS1 as a treatment for patients with relapsed/refractory multiple myeloma.

November 18, 2020 - The addition of the oral BTK inhibitor acalabrutinib to best supportive care in patients with respiratory symptoms from coronavirus disease 2019 infection failed to increase the proportion of patients who remained alive and free of respiratory failure, missing the primary efficacy end points of the 2 phase 2 CALAVI trials.

November 17, 2020 - AV-GBM-1, a personalized cancer vaccine, demonstrated an improvement in progression-free survival in patients with newly diagnosed glioblastoma.

November 17, 2020 - Primary chemoablation with UGN-102 was found to induce durable responses in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer.

November 17, 2020 - The PD-1 inhibitor tislelizumab was found to improve overall survival versus docetaxel in the second- or third-line treatment in patients with locally advanced or metastatic non–small cell lung cancer who progressed on previous platinum-based chemotherapy.

November 17, 2020 - The review of the biologics license application for the CAR T-cell product lisocabtagene maraleucel for the treatment of adult patients with relapsed/refractory large B-cell lymphoma following at least 2 previous therapies has been delayed.

November 16, 2020 — The United Kingdom’s National Institute for Health and Care Excellence has recommended caplacizumab-yhdp with plasma exchange and immunosuppression for the treatment of an acute episode of acquired thrombotic thrombocytopenic purpura in adults and those aged 12 years and over who weigh at least 40 kg.

November 16, 2020 — The FDA has approved the PD-L1 IHC 22C3 pharmDx to aid in the identification of patients with triple-negative breast cancer who are eligible to receive the PD-1 inhibitor pembrolizumab.

November 15, 2020 - The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for the fixed-dose combination of pertuzumab plus trastuzumab with hyaluronidase-zzxf for administration via subcutaneous injection in combination with intravenous chemotherapy in the treatment of patients with early and metastatic HER2-positive breast cancer

November 14, 2020 - A novel combination comprised of the TKI cabozantinib plus the PD-1 inhibitor nivolumab and the CTLA-4 inhibitor ipilimumab is under exploration in treatment-naïve patients with intermediate or poor risk advanced or metastatic renal cell carcinoma in the phase 3 COSMIC-313 trial.

November 13, 2020 - The FDA has granted an accelerated approval to pembrolizumab for use in combination with chemotherapy in the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1 as determined by an FDA-approved test.

November 13, 2020 - The addition of plasmid IL-12 pembrolizumab resulted in durable responses, as well as several complete responses, in patients with advanced melanoma who were refractory to PD-1–directed therapy.

November 12, 2020 - The first-in-class, next-generation, DuoBody-PD-L1×4-1BB bispecific antibody GEN1046 demonstrated promising early activity and an acceptable safety profile in in patients with advanced solid tumors.

Regulatory applications have been submitted to the FDA and the European Medicines Agency for subcutaneous daratumumab for use in combination with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma who have received at least 1 previous therapy.

The addition of the first-in-class targeted therapy bemarituzumab to chemotherapy significantly improved progression-free survival and overall survival versus chemotherapy alone in the frontline treatment of patients with FGFRb-positive, locally advanced or metastatic gastric and gastroesophageal junction cancer.

November 10, 2020 - The China National Medical Products Administration has approved enzalutamide for the treatment of adult patients with nonmetastatic castration-resistant prostate cancer who are at a higher risk of metastasis.

November 10, 2020 - The combination of pembrolizumab plus lenvatinib significantly improved progression-free survival, overall survival, and the objective response rate compared with sunitinib, when used in the frontline treatment of patients with advanced renal cell carcinoma.

November 10, 2020 - The European Union approved the next-generation BTK inhibitor acalabrutinib for use in adult patients with chronic lymphocytic leukemia.

The phase 3 KEYNOTE-598 trial evaluating the dual immunotherapy combination comprised of pembrolizumab and ipilimumab as frontline treatment in patients with metastatic non–small cell lung cancer who have a PD-L1 tumor proportion score of 50% or greater and do not harbor any EGFR or ALK aberrations has been discontinued.

The oncology community has risen up as a unified front in the battle against coronavirus disease 2019, 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, which is indicated for select patients with deleterious or suspected deleterious germline or somatic homologous recombination repair gene–mutated metastatic castration-resistant prostate cancer.

The combination of lenvatinib plus pembrolizumab demonstrated encouraging antitumor activity in patients with metastatic clear cell renal cell carcinoma who had progressed on prior PD-1 or PD-L1 immune checkpoint inhibitor therapy.

Neratinib showcased early activity when used in patients with metastatic non–small cell lung cancer who harbor EGFR exon 18 mutations.

The European Commission has approved the combination of nivolumab plus ipilimumab with 2 cycles of platinum-based chemotherapy for the up-front treatment of adult patients with metastatic non–small cell lung cancer without a sensitizing EGFR mutation or an ALK translocation.

Norman E. “Ned” Sharpless, MD, discusses the efforts that The National Cancer Institute has made to combat the coronavirus disease 2019 pandemic.

The European Union has approved olaparib in combination with bevacizumab for use as a first-line maintenance treatment in patients with homologous recombination deficient–positive advanced ovarian cancer.

A Type II variation application has been submitted by Janssen Pharmaceutica NV to the European Medicines Agency for the subcutaneous formulation of daratumumab in combination with bortezomib, cyclophosphamide, and dexamethasone for use in adult patients with light-chain amyloidosis.