Kristi Rosa

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.

December 23, 2020 - The FDA has granted an orphan drug designation to the mismatched, double-stranded RNA molecule rintatolimod for the treatment of patients with pancreatic cancer.

December 23, 2020 — Although SGX942 was found to induce clinically meaningful reductions in severe oral mucositis vs placebo in patients with head and neck cancer, the benefit failed to reach statistical significance, thus missing the primary end point of the phase 3 DOM-INNATE study.

December 23, 2020 - Entrectinib continued to demonstrate clinically meaningful, durable responses with a manageable toxicity profile in patients with NTRK fusion–positive sarcoma.

December 23, 2020 - The FDA has updated the prescribing information for ibrutinib to include safety and efficacy data for the agent in combination with rituximab in the treatment of patients with Waldenström macroglobulinemia.

December 22, 2020 — Intravesical Bacillus Calmette-Guerin in combination with N-803 was found to induce a complete response rate of 72% in patients with non-muscle invasive bladder cancer in high-risk carcinoma in situ disease, meeting the primary end point of the phase 2/3 QUILT 3.032 trial.

The small interfering RNA therapeutic STP705 has been found to induce high rates of histological clearance with a favorable toxicity profile in patients with squamous cell skin cancer.

December 22, 2020 — The FDA has approved an investigational new drug application for berubicin for the treatment of patients with glioblastoma multiforme.

December 21, 2020 - Rucaparib was found to result in a statistically significant improvement in progression-free survival compared with chemotherapy in patients with BRCA-mutant ovarian cancer who had previously received 2 or more lines of chemotherapy.