Kristi Rosa

December 4, 2020 - The completion of the biologics license application for balstilimab in the treatment of patients with recurrent or metastatic cervical cancer has been delayed to the first half of 2021.

December 3, 2020 — The survivin-targeted T-cell therapy DPX-Survivac, when used in combination with intermittent low-dose cyclophosphamide, prolonged clinical benefit with promising tolerability in patients with recurrent, advanced platinum-sensitive and -resistant ovarian cancer.

December 3, 2020 - Lurbinectedin plus doxorubicin failed to significantly improve overall survival versus physician’s choice of topotecan or cyclophosphamide/doxorubicin/vincristine in patients with small cell lung cancer who progressed after 1 previous platinum-containing line of treatment, missing the primary end point of the phase 3 ATLANTIS trial.

December 3, 2020 — A biologics license application has been submitted to the FDA for the EGFR-MET bispecific antibody amivantamab for the treatment of patients with metastatic non–small cell lung cancer with EGFR exon 20 insertion mutations who have progressed on or following a platinum-based chemotherapy.

December 2, 2020 - Patients with high-grade Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer who responded to the investigational gene therapy nadofaragene firadenovec had a lower rate of cystectomy and delayed time to cystectomy compared with those who did not respond.

December 1, 2020 - The FDA has approved pralsetinib for the treatment of select patients with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy or RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory.

December 1, 2020 - The FDA has approved Gallium 68 PSMA-11, the first drug for PET imaging of prostate-specific membrane antigen–positive lesions in patients with prostate cancer.

December 1, 2020 — The FDA has granted a fast track designation to irinotecan liposome injection as second-line monotherapy option for patients with small cell lung cancer whose disease progressed following a platinum-based chemotherapy regimen.

December 1, 2020 - A rolling submission of a biologics license application to the FDA has been initiated for the CD20-directed monoclonal antibody ublituximab in combination with the PI3K-delta and CK1-epsilon inhibitor umbralisib for the treatment of patients with chronic lymphocytic leukemia.

December 1, 2020 - The FDA has granted a priority review designation to the oral FGFR1-3 selective inhibitor infigratinib for the treatment of patients with cholangiocarcinoma.

November 24, 2020 - Pexidartinib was found to result in prolonged efficacy with favorable safety in patients with tenosynovial giant cell tumors, according to long-term data from a pooled analysis of 3 cohorts of patients who received the agent.

November 23, 2020 - Yelena Y. Janjigian, MD, discusses future research efforts are focused on examining anti–PD-1 combination strategies, particularly with HER2-directed therapies.

November 23, 2020 - The China National Medical Products Administration has approved denosumab for the prevention of skeletal-related events in patients with bone metastases from solid tumors and in those with multiple myeloma.

November 23, 2020 - Ripretinib demonstrated clinically meaningful activity in patients with fourth-line or later advanced gastrointestinal stromal tumor and several, heterogeneous genetic subsets of KIT/PDGFRA mutations.

November 21, 2020 - Frontline sintilimab injection in combination with bevacizumab biosimilar injection resulted in a significant improvement in overall survival and progression-free survival per Independent Radiographic Review Committee versus sorafenib in patients with advanced unresectable hepatocellular carcinoma.

November 20, 2020 - Patients from Asian countries with hormone receptor–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.

November 20, 2020 - The FDA has granted a priority review designation to a biologics license application for loncastuximab tesirine for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma.

November 20, 2020 - The FDA has approved durvalumab for an additional dosing option, a fixed dose of 1500 mg every 4 weeks, in the approved indications of unresectable stage III non-small cell lung cancer after chemoradiation and previously treated advanced bladder cancer.

November 19, 2020 - A computational method comprised of clinicodemographic variables with deep learning of pretreatment histology images may be able to effectively predict response to immunotherapy in patients with advanced melanoma.

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.