Kristi Rosa

January 14, 2020 — The National Medical Products Administration of China has accepted a supplemental new drug application for sintilimab injection for use in the second-line treatment of patients with squamous non–small cell lung cancer.

January 14, 2020 - The China National Medical Products Administration has approved tislelizumab for use in combination with 2 chemotherapy regimens in the frontline treatment of patients with advanced squamous non–small cell lung cancer.

January 13, 2021 — The FDA has granted an orphan drug designation to the BCMA-targeted trispecific T-cell activating recombinant protein construct as treatment for patients with multiple myeloma.

January 13, 2021 - Health Canada has approved the combination of ibrutinib and rituximab for use in patients with treatment-naïve chronic lymphocytic leukemia.

January 12, 2021 - Palbociclib in combination with endocrine therapy failed to result in a statistically significant improvement in progression-free survival over capecitabine in patients with hormone receptor–positive metastatic breast cancer who were resistant to aromatase inhibitors.

January 11, 2021 - The FDA has granted fast track designations to cavrotolimod for use in combination with a PD-1 therapy in patients with locally advanced or metastatic Merkel cell carcinoma 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 that is refractory to previous PD-1/PD-L1 blockade.

January 11, 2021 — The FDA has granted an orphan drug designation to the novel intratumoral immunotherapy agent PVSRIPO for the treatment of patients with advanced melanoma, specifically those with stage IIIB-IV disease.

January 11, 2021 - Larotrectinib was found to induce a high response rate with long durability and improve survival in patients with TRK-positive sarcomas, according to results from an analysis of 3 clinical trials.

January 8, 2021 — The combination of osimertinib plus bevacizumab failed to result in a statistically significant improvement in progression-free survival versus osimertinib alone in patients with advanced lung adenocarcinoma that harbored an EGFR T790M mutation.

January 8, 2021 - The FDA has approved a supplemental new drug application to add overall survival and other secondary end point data from the phase 3 ARAMIS trial to the prescribing information for darolutamide for the treatment of patients with nonmetastatic prostate cancer.

January 8th, 2021 - The United Kingdom’s National Institute for Health and Care Excellence has issued guidelines recommending against nivolumab for use in patients with recurrent or metastatic head and neck squamous cell carcinoma who experienced disease progression during or after platinum-based chemotherapy.

January 8, 2021 — The FDA has granted a fast track designation to zenocutuzumab for the treatment of patients with metastatic solid tumors that harbor NRG1 gene fusions and have progressed on standard-of-care treatment.

January 7th, 2021 - The addition of eganelisib to nivolumab was found to elicit encouraging responses and improve progression-free survival compared with single-agent nivolumab in patients with platinum-refractory, immunotherapy-naïve, advanced, metastatic urothelial cancer.

January 7, 2020 - The FDA has approved the request submitted by Moleculin Biotech, Inc. for rare disease designations to be granted their drug candidate WP1066, an agent that appears to directly elicit tumor cell death and rouse the immune system to eliminate tumors.

January 6, 2021 — The oral small molecule inhibitor VS-6766, developed by Verastem Oncology, is now under investigation alone and in combination with the FAK inhibitor defactinib in a recently initiated, registration-directed, phase 2 trial in patients with recurrent low-grade serous ovarian cancer.

January 6, 2020 - The FDA has deferred action on the biologics license application for the proposed bevacizumab biosimilar MYL-1402O.

January 5th, 2021 -The FDA has granted a fast track designation to the investigational antibody-drug conjugate 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.

January 5, 2020 - A new drug application has been submitted to Japan’s Ministry of Health, Labour, and Welfare for the oncolytic virus teserpaturev for use in the treatment of patients with malignant glioma.

January 5th, 2021 - The FDA has granted a breakthrough therapy designation to the anti-TIGIT therapy tiragolumab for use in combination with atezolizumab in the frontline treatment of patients with metastatic non–small cell lung cancer whose tumors are PD-L1 high and do not harbor any EGFR or ALK aberrations.

January 5th, 2021 - Ripretinib is under investigation as a second-line treatment in patients with gastrointestinal stromal tumor versus sunitinib in the phase 3 INTRIGUE trial, which recently completed its target enrollment.

January 4th, 2021 - A marketing authorization application has been submitted to the European Medicines Agency for the approval of amivantamab as a treatment for patients with metastatic non–small cell lung cancer that harbors EGFR exon 20 insertion mutations who have experienced disease progression following platinum-based chemotherapy.

January 4, 2021 - A marketing authorization application has been submitted to the European Medicines Agency for the use of sotorasib in patients with KRAS G12C–mutated locally advanced or metastatic non–small cell lung cancer.

January 4, 2021 - The biologics license application for the CAR T-cell product lisocabtagene maraleucel in adult patients with relapsed/refractory large B-cell lymphoma following at least 2 previous therapies continues to be under regulatory review by the FDA, and a decision on the application has not yet been reached.

The combination of telaglenastat plus cabozantinib failed to result in a significant improvement in progression-free survival in patients with advanced or metastatic renal cell carcinoma.

December 30, 2020 - Bristol Myers Squibb has withdrawn nivolumab from the US market for the treatment of patients with small cell lung cancer who have experienced disease progression after a platinum-based chemotherapy and at least 1 other line of therapy.

December 30, 2020 - The China National Medical Products Administration has approved surufatinib for the treatment of patients with non-pancreatic neuroendocrine tumors.

December 28, 2020 - The FDA has granted priority review to a supplemental new drug application for lorlatinib for use as a frontline treatment in patients with ALK-positive metastatic non–small cell lung cancer.

December 23, 2020 - Pacritinib, when delivered at a twice-daily dose of 200 mg, was found to demonstrate clinical activity with an acceptable toxicity profile in patients with myelofibrosis and severe thrombocytopenia.

December 23, 2020 — Nivolumab in combination with temozolomide and radiation treatment failed to result in a statistically significant improvement in overall survival in patients with newly diagnosed glioblastoma multiforme with MGMT promoter methylation following surgical resection of the tumor.

December 23, 2020 - The European Commission has approved the fixed-dose combination of pertuzumab and trastuzumab with hyaluronidase, to be administered via a subcutaneous injection in the treatment of patients with early and metastatic HER2-positive breast cancer.