Silas Inman

Daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone received FDA approval as a frontline regimen for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

Patients with metastatic or recurrent squamous cell carcinoma of the head and neck experienced a 32% reduction in the risk of death compared with investigator's choice of therapy, according to updated findings with a minimum of 2 years of follow-up from the phase III CheckMate-141 study.

After findings from 2 randomized trials and an open-label extenstion study were released, fostamatinib (Tavalisse), anSYK inhibitor, was approved by the FDA as a second-line treatment following insufficient response to a previous therapy for patients with chronic immune thrombocytopenia.

In a precision medicine success story, crizotinib (Xalkori) demonstrated a 50% objective response rate and a 100% disease control rate in patients with&nbsp;<em>ALK</em>-positive advanced, inoperable inflammatory tumors, in findings from the CREATE study presented at the 2018 AACR Annual Meeting.&nbsp;

Abemaciclib, the only CDK4/6 inhibitor approved as a single-agent, has amassed several clinical indications for patients with metastatic breast cancer. The findings from the phase III MONARCH2 and 3 trials, as well as the phase II MONARCH1 study led to these approvals. Each trial showed improvements in progression-free survival, especially in patients with visceral disease and endocrine therapy resistance.

Presented at the 2018 Miami Breast Cancer Conference, results from the phase III OlympiAD trial demonstrated improvements in progression-free survival with olaparib over treatment of physician&#39;s choice. These results were consistent regardless of the baseline tumor burden for patients with HER2-negative breast cancer with a germline <em>BRCA</em>1/2 mutation.

Based on findings from a phase I trial presented at the 2017 ASH Annual Meeting, ivosidenib (AG-120) has been granted a priority review designation by the FDA for the&nbsp;treatment of patients with relapsed/refractory <em>IDH1</em>-mutant acute myeloid leukemia.

In findings from the phase III PROSPER trial released ahead of the&nbsp;2018 Genitourinary Cancers Symposium, the&nbsp;enzalutamide (Xtandi) and androgen deprivation therapy (ADT) combination&nbsp;reduced the risk of metastases or death by 71% compared with ADT alone for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC).

As stated in findings from IMmotion151, a phase III open-label study, the combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) induced a 26% reduction in the risk of progression or death compared with sunitinib (Sutent) for patients with untreated PD-L1&ndash;positive metastatic renal cell carcinoma. This study was released ahead of the 2018 Genitourinary Cancers Symposium.

The combination of abiraterone acetate in combination with prednisone and androgen deprivation therapy has been approved by the FDA as a treatment for men with high-risk castration-sensitive prostate cancer.

According to findings from the phase III&nbsp;CELESTIAL trial released ahead of the&nbsp;2018 Gastrointestinal Cancers Symposium,&nbsp;cabozantinib (Cabometyx) improved median overall survival by 2.2 months compared with placebo&nbsp;for patients with previously treated advanced hepatocellular carcinoma.

In patients with newly diagnosed locally advanced pancreatic cancer, induction treatment with nab-paclitaxel (Abraxane) plus gemcitabine induced an overall disease control rate of 77.6%, according to&nbsp;updated findings from the phase II LAPACT trial presented at the 2018 Gastrointestinal Cancers Symposium.

Based on findings from the&nbsp;ALCYONE study,&nbsp;which were published in the <em>New England Journal of Medicine</em> and presented at the 2017 ASH Annual Meeting,^&nbsp;the FDA has granted a priority review designation to&nbsp;daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

Arsenic trioxide (Trisenox) has been approved by the FDA in&nbsp;combination with the all-trans retinoic acid agent tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia with the t(15;17) translocation or <em>PML-RARA</em> gene expression.

The frontline indication for afatinib (Gilotrif) has been expanded by the FDA to include&nbsp;the treatment of patients with metastatic non&ndash;small cell lung cancer whose tumors harbor uncommon <em>EGFR</em> alterations in L861Q, G719X, and/or S768I.

A new drug application for the novel version of the&nbsp;radiopharmaceutical iobenguane I-131 (Azedra) has been granted a priority review by the FDA for the treatment of patients with malignant or recurrent&nbsp;pheochromocytoma or paraganglioma,&nbsp;according to a statement from Progenics Pharmaceuticals, the company developing the novel iodine-131 metaiodobenzylguanidine.

Based on results of a phase I trial presented at the 2017 ASH Annual Meeting, a new drug applicaton for ivosidenib has been submitted for FDA approval for the treatment of patients with&nbsp;relapsed/refractory IDH1-mutant acute myeloid leukemia, according to a statement from Agios Pharmaceuticals, the company developing the targeted therapy.

Based on findings from a 17-patient study, a novel breast-specific stereotactic body radiotherapy (SBRT) device known as GammaPod has been approved by the FDA as a treatment for patients with early breast cancer.<br /> <br /> &nbsp;

Bosutinib (Bosulif) has been approved by the FDA as a first-line treatment for&nbsp;patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML).

The combination of the novel tumor-associated macrophage (TAM)-targeting agent cabiralizumab and the PD-1 inhibitor nivolumab (Opdivo) resulted in intriguing objective response rates in heavily pretreated patients with metastatic pancreatic cancer, according to findings from a phase I study presented at the 2017 SITC Annual Meeting.

Ivosidenib (AG-120), an IDH1 inhibitor, demonstrated an objective response rate (ORR) of 41.6% in patients&nbsp;with relapsed/refractory&nbsp;<em>IDH1</em>-mutant acute myeloid leukemia (AML), according to findings from a single-arm phase I study.&nbsp;

According to phase II findings from the MEDIOLA trial presented at the 2017 San Antonio Breast Cancer Symposium,&nbsp;the combination of olaparib and durvalumab demonstrated a disease control rate of 80% for pretreated patients with germline <em>BRCA-</em>mutated, HER2-negative metastatic breast cancer, according to phase II findings from the MEDIOLA trial.

According to early results from a pilot trial presented in a poster at the 2017 San Antonio Breast Cancer Symposium,&nbsp;the combination of abemaciclib and pembrolizumab showed preliminary signs of activity without additive toxicity for patients with pretreated HR-positive, HER2-negative metastatic breast cancer.

Daratumumab (Darzalex) in combination with VMP (bortezomib [Velcade], melphalan, and prednisone) could become a new standard of care for patients with newly diagnosed multiple myeloma who are unable to undergo transplant following findings from the phase III ALCYONE study.

Chimeric antigen receptor T-cell therapy with bb2121 demonstrated an objective response rate of 94% in patients with&nbsp;relapsed/refractory multiple myeloma, according to findings from a dose-escalation study. The senior study author, James N. Kochenderfer, MD, presented updated findings from the study during the 2017 ASH Annual Meeting, and commented that 89% of patients had a very good partial response or better, and 56% of patients had a complete remission.&nbsp;<br /> &nbsp;

Updated results from the TRANSCEND study demonstrated that&nbsp;liso-cel (lisocabtagene maraleucel), formally known as JCAR017, induced an 81% objective response rate and a 63% complete remission rate in patients with relapsed/refractory diffuse large B-cell lymphoma.

In patients with&nbsp;relapsed/refractory chronic lymphocytic leukemia (CLL), ibrutinib (Imbruvica) in combination with venetoclax (Venclexta) induced an objective response rate (ORR) of 100%, according to findings from the TAP CLARITY clinical trial.&nbsp;

Treatment with the chimeric antigen receptor T-cell therapy axi-cel&nbsp;(axicabtagene ciloleucel; Yescarta) demonstrated improvement in long-term survival rates in patients with refractor, aggressive non-Hodgkin lymphoma,&nbsp;according to updated findings from the pivotal ZUMA-1 trial.

Survival rates improved with nab-paclitaxel (Abraxane) therapy compared with paclitaxel in patients with triple-negative breast cancer (TNBC) more than in other patient subsets, according to findings from a post-hoc analysis from the CALGB 40502/NCCTG N063H clinical trial.&nbsp;

Updated results of the&nbsp;phase Ib/II ENHANCE1/KEYNOTE-150 study presented at the 2017 San Antonio Breast Cancer Symposium found that the combination of&nbsp;pembrolizumab (Keytruda) and eribulin (Halaven) was associated with a 26.4% objective response rate for patients with metastatic triple-negative breast cancer.