News

A new drug application has been filed for accelerated approval with the FDA for lurbinectedin in patients with small cell lung cancer who have progressed after prior platinum-containing therapy, according to the manufacturer, PharmaMar.1 The filing was based on results from a phase II basket trial, presented at the 2019 ASCO Annual Meeting.

A Biologic License Application has been submitted for isocabtagene maraleucel, a chimeric antigen receptor T-cell agent, as a treatment for adult patients with relapsed or refractory large B-cell lymphoma after a minimum of 2 prior therapies, Bristol-Myers Squibb, the manufacturer, reported in a press release.

Enfortumab vedotin-ejfv has been approved by the FDA for treatment of patients with locally advanced or metastatic urothelial cancers who had prior treatment with a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy regimen, according to a press release from the FDA.<br /> &nbsp;

The FDA has accepted a supplemental new drug application for the combination of encorafenib and cetuximab for the treatment of patients with advanced&nbsp;BRAF&nbsp;V600E-mutant metastatic colorectal cancer, following 1 or 2 lines of therapy, Pfizer, Inc. reported in a press release.<br /> &nbsp;

In a unanimous vote, the Oncologic Drugs Advisory Committee of the FDA is in favor of the benefit-risk profile of tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma who are not eligible for curative intent surgery, according to a press release from Epizyme, Inc., manufacturer of the drug.

In cohort 1 of the phase III ASPEN trial, zanubrutinib demonstrated a higher very good partial response rate and a more tolerable safety profile compared with ibrutinib in patients with Waldenstr&ouml;m macroglobulinemia. However, the study missed its primary end point of statistically significant superiority in complete response and VGPR rates, according to a press release from BeiGene, Ltd, developer of the BTK inhibitor.

The FDA has granted Breakthrough Therapy Designation to the addition of tucatinib to trastuzumab and capecitabine for the treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including those with brain metastases who received prior treatment with trastuzumab, pertuzumab, and T-DM1, according to a press release from Seattle Genetics.<br /> &nbsp;

Initial data from the phase II CLOVER-1 trial demonstrated an acceptable safety profile for CLR 131 in patients with relapsed/refractory B-cell malignancies, including multiple myeloma, Cellectar Biosciences, Inc., announced in a press release.

Results of the phase II DREAMM-2 trial recently published in The Lancet Oncology showed that the investigational agent belantamab mafodotin induced response rates above 30% and had a manageable safety profile in patients with heavily pretreated multiple myeloma.

In an interview with Targeted Oncology, Jeff P. Sharman, MD, discussed the updated ELEVATE-TN data and ongoing research that is poised to define the optimal role of acalabrutinib in CLL at the 2019 ASH Annual Meeting.

In a 7-to-5 vote, the FDA&rsquo;s Oncologic Drugs Advisory Committee recommended the PARP inhibitor olaparib as first-line maintenance therapy for patients with germline&nbsp;BRCA-mutated metastatic pancreatic cancer whose disease did not progress after first-line treatment with platinum-based chemotherapy, AstraZeneca and MSD, Inc. reported in a press release.<br /> &nbsp;

In an interview with&nbsp;Targeted Oncology, Pinkal Desai, MD, discussed the latest advancements in the treatment landscape for patients with AML, particularly for the older population. She also highlighted emerging treatment options that undergoing investigation now in clinical trials.

The FDA has granted a Fast Track Designation to tipifarnib, a farnesyl transferase inhibitor, for the treatment of patients with <em>HRAS</em>-mutant head and neck squamous cell carcinomas who have previously progressed on platinum therapy, according to a press release from Kura Oncology.

SP-2577, a potent reversible LSD1 inhibitor, has been granted Fast Track Designation by the FDA for the treatment of relapsed/refractory patients with Ewing sarcoma, Salarius Pharmaceuticals, Inc. developers of the drug, announced in a press release.

Interim phase II trial data showed that the combination of enasidenib, an oral small molecule inhibitor of mutant&nbsp;IDH2&nbsp;proteins, and azacitidine, significantly improves complete remission and overall responses in patients with newly diagnosed acute myeloid leukemia with&nbsp;IDH2&nbsp;mutations compared with azacitidine alone, according to results presented at the 2019 American Society of Hematology Annual Meeting.

Enzalutamide is now approved by the FDA for the treatment of metastatic castration-sensitive prostate cancer, making it the first oral agent to be approved for three different types of advanced prostate cancer, according to a press release from Pfizer.<br /> &nbsp;

The Association of Community Cancer Centers has partnered with the AIM at Melanoma Foundation to develop resources through its Multidisciplinary Cutaneous Squamous Cell Carcinoma Care education project to help provide physicians with more information to guide them in the diagnosis and treatment of patients with this type of nonmelanoma skin cancer, according to a press release from ACCC.

MI Genomic Profiling Similarity Score, the latest addition to the comprehensive genomic profiling armamentarium at Caris Life Sciences, has been launched, according to a press release from the company

A New Drug Application for ripretinib was submitted to the FDA for the treatment of patients with advanced gastrointestinal stromal tumor who have received a prior treatment of imatinib, sunitinib, and regorafenib, according to a press release from Deciphera Pharmaceuticals, Inc.

Pembrolizumab showed improvements in overall survival, progression-free survival, and objective response rate compared with pemetrexed or paclitaxel chemotherapy in patients with metastatic nonsquamous non&ndash;small cell lung cancer whose tumors are PD-L1&ndash;positive, regardless of their&nbsp;KRAS&nbsp;mutational status.

Historically, colorectal cancer has been viewed as a common cancer among elderly patients. The average age at diagnosis of patients with colorectal cancer in the United States is 67 years,&nbsp;in which a screening colonoscopy remains the gold standard of care for prevention and is recommended for all individuals &gt;50 years of age.

In an interview with&nbsp;Targeted Oncology, Brennan J. Decker, MD, PhD, discussed a real-life scenario of a patient with lung cancer who harbored both an&nbsp;EGFR&nbsp;and&nbsp;BRAF&nbsp;mutation. He highlighted the key takeaways of this case, which he presented at the 2019 Association for Molecular Pathology Annual Meeting and Expo.

The United States Senate has voted to confirm Stephen M. Hahn, MD, FASTRO, as commissioner of Food and Drugs, Department of Health and Human Services during a U.S. Senate floor proceeding held on Thursday, December 12, 2019, according to a press release from the HHS. The vote was 72 to 18.

Preliminary data showed that the combination of sitravatinib and tislelizumab is well tolerated and may promote antitumor activity when administered to patients with platinum-resistant ovarian cancer, according to a press release from BieGene, Ltd, which reported data from a phase Ib study at the 2019 European Society of Oncology Immuno-Oncology Congress in Geneva, Switzerland.<br /> &nbsp;

During a Targeted Oncology&trade; case-based peer perspectives live discussion, Ravi&nbsp;Vij,&nbsp;MD, MBA, professor, Department of Medicine, Oncology Division, Bone Marrow Tranplantation &amp; Leukemia, Washington University School of Medicine in St. Louis spoke with a group of oncologists about best practices for treating patients with multiple myeloma. The ideas he presented were based on a real case of a male patient with multiple myeloma.

With the inevitability of resistance to first- and second-generation EGFR tyrosine kinase inhibitors in patients with EGFR-mutant non&ndash;small cell lung cancer, novel options like lazertinib, an irreversible, third-generation, mutant-selective, EGFR TKI are being explored. Lazertinib has shown promise for the treatment of this patient population, according to a phase I/II dose-escalation study published in The Lancet Oncology.

The combination of atezolizumab, cobimetinib, and vemurafenib reduced the risk of disease progression or death compared with placebo in patients with&nbsp;BRAF&nbsp;V600 mutation-positive advanced melanoma, meeting the primary endpoint of progression-free survival in the phase III IMspire150 study, according to a press release from Roche.

In a&nbsp;Targeted Oncology&nbsp;case-based peer perspectives live discussion, Nathan A. Pennell, MD, PhD, associate professor of the Department of Medicine at Case Western Reserve University and a medical oncologist at Taussig Cancer Center and the Cleveland Clinic Cancer Center discussed treatment options for EGFR-mutant non&ndash;small cell lung cancer, based on the case of a real patient.<br /> &nbsp;

Some HNSCCs are characterized by exclusion of immune cells, and the presence of indoleamine-dioxygenase&nbsp;and myeloid-derived suppressor cells indicates a suppressive tumor microenvironment. The PD-1&ndash;directed antibodies pembrolizumab and nivolumab and the PD-L1&ndash;directed antibodies durvalumab, and atezolizumab have demonstrated single-agent activity in HNSCC, leading to multicenter phase Ib, II, and III trials defining new standards of care in recurrent/ metastatic HNSCC.

New results from the KEYNOTE-164 trial have shown that patients with previously treated microsatellite instability-high DNA mismatch repair advanced or metastatic colorectal cancer who received pembrolizumab responded well to the drug.