Daratumumab (Darzalex) has been submitted for FDA approval for use in combination with bortezomib (Velcade), melphalan and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT).
In findings from the phase III JAVELIN Gastric 300 trial, survival was not improved with the anti–PD-L1 agent avelumab compared with chemotherapy in previously treated patients with gastric or gastroesophageal junction adenocarcinoma.<br />
A biologics license application for mogamulizumab has been granted a priority review by the FDA for the treatment of patients with cutaneous T-cell lymphoma who have received at least 1 prior systemic therapy, Kyowa Hakko Kirin, the manufacturer of the anti-CCR4 monoclonal antibody, has announced.
AstraZeneca has submitted a supplemental new drug application to Japan's Pharmaceuticals and Medical Devices Agency for the use of the third-generation, irreversible EGFR tyrosine kinase inhibitor osimertinib (Tagrisso) in the frontline treatment of patients with inoperable or recurrent <em>EGFR</em>-positive non–small cell lung cancer.
In data presented at the 2017 ESMO Asia Congress, updated results again sustained the benefit of frontline osimertinib (Tagrisso) in patients with <em>EGFR</em>-positive advanced non–small cell lung cancer (NSCLC) and CNS metastases at baseline.
Nilotinib (Tasigna) has been approved by the FDA for the treatment of pediatric patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase. The approval is both in the frontline setting and for those with resistance or intolerance to prior therapy, including imatinib.
Sunitinib (Sutent) has been granted FDA approval for the adjuvant treatment of patients with renal cell carcinoma (RCC) who have received nephrectomy and are high risk for recurrence.
Obinutuzumab (Gazyva) has been approved by the FDA in combination with chemotherapy, followed by obinutuzumab alone, for the first-line treatment of patients with advanced follicular lymphoma, according to Genentech, the manufacturer of the therapy.
Alectinib (Alecensa) has received FDA approval for the frontline treatment of patients with ALK-positive metastatic non–small cell lung cancer, Genentech, the manufacturer of the second-generation ALK inhibitor, announced today.
Intravenous rolapitant (Varubi) has received FDA approval for use in combination with other antiemetic agents to treat delayed chemotherapy-induced nausea and vomiting in adults, according to TESARO, the manufacturer of the agent.
According to data presented at the 2017 World Congress of Melanoma, the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) induced a 3-year relapse-free survival rate of 71% in the adjuvant treatment of patients with high-risk resected stage IIIC/IV melanoma, but it was also associated with significant toxicity.
Based on data from the phase III MONARCH 3 trial, a new drug application for abemaciclib (Verzenio) has been granted a priority review by the FDA for use in combination with an aromatase inhibitor for the frontline treatment of women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.
Based on findings from the phase III ARIEL3 trial, a supplemental new drug application has been submitted to the FDA for rucaparib as maintenance therapy for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
The FDA has approved a supplemental new drug application for the use of 180-mg tablets of brigatinib (Alunbrig) for the treatment of patients with non–small cell lung cancer.
A supplemental biologics license application for pertuzumab (Perjeta) for use in combination with trastuzumab (Herceptin) and chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer has been granted a priority review by the FDA.
Abemaciclib (Verzenio) has been approved by the FDA for use as a monotherapy and in a combination regimen for patients with HR-positive/HER2-negative breast cancer. As a monotherapy, the CDK4/6 inhibitor has been approved for patients with metastatic disease who have previously received endocrine therapy and chemotherapy, and as a combination, abemaciclib has been approved for use with fulvestrant for women with advanced breast cancer with disease progression following endocrine therapy.
Based on findings from the phase II KEYNOTE-059 study, pembrolizumab has been granted FDA approval for the treatment of patients with PD-L1–positive recurrent or advanced gastric or gastroesophageal junction adenocarcinoma who have received 2 or more lines of chemotherapy, including fluoropyrimidine- and platinum-containing chemotherapy, and, if appropriate, HER2/neu-targeted therapy.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 6-6 on the potential approval of sunitinib (Sutent) for use as an adjuvant therapy in patients with renal cell carcinoma (RCC) who have received nephrectomy and are at high risk of recurrence. The FDA will take this vote into consideration when determining its final approval decision, which is scheduled to be made by January 2018.
Based primarily on findings from the phase II CHRONOS-1 trial, copanlisib (Aliqopa) has received an accelerated approval from the FDA as a treatment for patients with relapsed follicular lymphoma who have received at least 2 prior systemic therapies.
Pembrolizumab has been approved by the European Commission for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy, or who are not eligible for cisplatin-containing chemotherapy.
An overall response rate of 61% was induced by adding the IDO inhibitor indoximod to pembrolizumab in patients with advanced melanoma, according to updated results presented at the International Cancer Immunotherapy Conference in Frankfurt/Mainz, Germany.
The decision deadline on a biologics license application (BLA) for MYL-1401O, a trastuzumab (Herceptin) biosimilar co-developed by Mylan and Biocon, has been extended by 3 months, the FDA has announced. Under the new timeframe, a final decision is expected on or before December 3, 2017.
The FDA recently released a statement providing specific data from 2 phase III trials placed on hold in July investigating pembrolizumab (Keytruda) in multiple myeloma.
A supplemental new drug application seeking to add overall survival data from the phase III ENDEAVOR trial to the label for carfilzomib (Kyprolis) for use in patients with relapsed or refractory multiple myeloma has been accepted by the FDA.
Fulvestrant (Faslodex) has been approved by the FDA for use in hormone receptor-positive, HER2-negative locally-advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy.
The CDK 4/6 inhibitor ribociclib (Kisqali) has been approved by the European Commission for use in combination with an aromatase inhibitor for the frontline treatment of postmenopausal women with hormone-receptor (HR)–positive, HER2-negative locally advanced or metastatic breast cancer.
Exelixis has submitted a supplemental New Drug Application to the FDA for the multikinase inhibitor cabozantinib as treatment for previously untreated patients with advanced renal cell carcinoma.
Ibrutinib (Imbruvica) has been approved by the FDA for the treatment of adult patients with chronic graft versus host disease (cGVHD) following the failure of 1 or more lines of systemic therapy. The BTK inhibitor is now the first FDA-approved therapy for the treatment of cGVHD.
Nivolumab (Opdivo) has been granted an accelerated approval by the FDA for the treatment of adult and pediatric patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
The FDA has granted breakthrough therapy designation to venetoclax (Venclexta) for use in combination with low dose cytarabine (LDAC) in treatment-naïve elderly patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy, according to Roche, which is codeveloping the BCL-2 inhibitor with AbbVie.