Based on findings from the phase III ECHELON-1 trial, a supplemental biologics application (sBLA) for brentuximab vedotin (Adcetris) in combination with Adriamycin, vinblastine, and dacarbazine (AVD) has been granted a priority review by the FDA for the frontline treatment of advanced classical Hodgkin lymphoma, according to a statement from the company developing the CD30-targeted antibody-drug conjugate, Seattle Genetics.
The label for nilotinib (Tasigna) has been updated by the FDA with a provision stating patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) who have received the BCR-ABL tyrosine kinase inhibitor could be eligible to stop treatment after having recieved for at least 3 years and having achieved the specific predetermined criteria.<br /> <br />
Based on findings of the phase III COMBI-AD study, a supplemental new drug application for dabrafenib (Tafinlar) combined with trametinib (Mekinist) has been granted a priority review by the FDA as an adjuvant treatment for patients with <em>BRAF</em> V600E– or V600K–positive stage III melanoma following complete resection.
The PD-L1 inhibitor avelumab (Bavencio) has been granted a breakthrough therapy designation by the FDA for use in combination with the VEGF inhibitor axitinib (Inlyta) in treatment-naïve patients with advanced renal cell carcinoma.
Based on data from the phase III SPARTAN trial, apalutamide has been granted a priority review by the FDA for the treatment of patients with nonmetastatic castration-resistant prostate cancer, according to Janssen Biotech, the manufacturer of the next-generation oral androgen receptor inhibitor.
According to findings from the phase I SCOUT trial, the novel pan-TRK inhibitor larotrectinib (LOXO-101) achieved a 93% response rate in pediatric patients with <em>TRK</em> fusion–positive solid tumors.
A supplemental new drug application (sNDA) for osimertinib (Tagrisso) has been granted a priority review by the FDA as a first-line treatment for patients with non–small cell lung cancer (NSCLC) whose tumors harbor <em>EGFR</em> mutations (exon 19 deletions or exon 21 [L858R] substitution mutations).
Based on findings of the phase III CheckMate-214 trial, a supplemental biologics license application for the combination of nivolumab and ipilimumab has been granted a priority review by the FDA as a frontline treatment for intermediate- and poor-risk patients with advanced renal cell carcinoma.
Treatment with the novel PD-1 inhibitor cemiplimab induced responses in half of the patients with Hodgkin lymphoma in a phase I study of patients with B-lymphoid malignancies; among patients with B-cell non-Hodgkin lymphoma treated with the monotherapy, the overall response rate was 11.1%, according to a poster presentation at the 2017 ASH Annual Meeting.
Treatment with tisagenlecleucel (Kymriah) continues to excite the possibilities seen with chimeric antigen receptor T-cell therapy with impressive responses seen with the therapy in patients with relapsed/refractory diffuse large B-cell lymphoma. In the phase II JULIET trial, an overall response rate of 53.1% was observed, according to findings presented at the ASH Annual Meeting.
According to results of a phase Ib/II trial presented at the 2017 ASH Annual Meeting, the frontline triplet regimen of atezolizumab (Tecentriq), obinutuzumab (Gazyva), and bendamustine was associated with an overall response rate (ORR) of 85% (Modified Lugano criteria; independent review) in patients with follicular lymphoma.
Mogamulizumab improved progression-free survival in previously treated patients with cutaneous T-cell lymphoma by 4.6 months compared with vorinostat (Zolinza), according to findings from the phase III MAVORIC study.
Results of the phase III SOLD trial maintained the benefit of 12 months of adjuvant treatment with trastuzumab (Herceptin) for patients with early stage HER2-positive breast cancer, as the trial failed to demonstrate noninferiority for 9 weeks of trastuzumab versus the standard 1-year period, when added to chemotherapy.
Based on results from the phase III ARIEL3 trial, in which maintenance rucaparib improved median progression-free survival by 11.2 months versus placebo for patients with <em>BRCA</em>-mutant platinum-sensitive ovarian cancer, the FDA has granted the PARP inhibitor a priority review.
In results from the phase Ib/II PANACEA trial presented at the 2017 San Antonio Breast Cancer Symposium (SABCS), the combination of pembrolizumab (Keytruda) and trastuzumab (Herceptin) achieved an objective response rate (ORR) of 15.2% in patients with trastuzumab-resistant, PD-L1–positive, HER2-positive breast cancer.
After previously receiving an accelerated approval, bevacizumab (Avastin) has been granted a full approval by the FDA for the treatment of adult patients with glioblastoma that progressed following prior therapy, according to Genentech, the manufacturer of the VEGF inhibitor.
The partial clinical holds placed on the phase I CheckMate-039 and phase II CA204142 trials in October were lifted today by the FDA. Both trials were exploring nivolumab-based regimens in patients with relapsed/refractory multiple myeloma.
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.