Kristi Rosa

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December 30, 2020 - Bristol Myers Squibb has withdrawn nivolumab from the US market for the treatment of patients with small cell lung cancer who have experienced disease progression after a platinum-based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

December 21, 2020 — The addition of gilteritinib to azacitidine failed to significantly improve overall survival vs azacitidine alone in patients with newly diagnosed FLT3-mutated acute myeloid leukemia who were not eligible for intensive induction chemotherapy, failing to meet the primary end point of the LACEWING trial.

December 21, 2020 - Cabozantinib was found to significantly improve progression-free survival compared with placebo in patients with dedifferentiated thyroid cancer who are refractory to radioiodine and have progressed following up to 2 prior VEGF-targeted treatments.

December 21, 2020 - The submission of a biologics license application to the FDA has been initiated for JZP-458 for use as a component of a multiagent chemotherapy regimen in the treatment of adult and pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma.

December 21, 2020 - A rolling submission of the biologics license application for the BCMA-directed CAR T-cell product ciltacabtagene autoleucel for use in adults with relapsed/refractory multiple myeloma has been initiated to the FDA.

December 18, 2020 - The FDA has granted Emergency Use Authorization to the second vaccine to prevent coronavirus disease 2019 infection.

December 18, 2020 - 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.

December 18, 2020 - The FDA has approved osimertinib 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.

December 18, 2020 - The FDA has approved the oral gonadotropin-releasing hormone receptor antagonist relugolix as a treatment for patients with advanced prostate cancer.

December 18, 2020 - The FDA has approved selinexor in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 1 previous therapy.

December 18, 2020 - A supplemental new drug application has been submitted to the FDA for avapritinib for use as a treatment in adult patients with advanced systemic mastocytosis.

December 17, 2020 - The FDA’s Vaccines and Related Biological Products Advisory Committee has voted 20-0 with 1 abstention to support the benefit-risk profile associated with the coronavirus disease 2019 vaccine mRNA-1273.