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Oncology Experts Reflect on Most Impactful FDA Approvals in 2018

Danielle Ternyila
Published Online:8:00 PM, Wed December 26, 2018
FDA In 2018, the FDA approved a number of agents for a variety of indications across hematologic malignancies, lung cancer, breast cancer, and more. In addition, several biosimilars received approval this year.

On Twitter, Targeted Oncology asked its followers what field had the most impactful approvals in 2018. While hematologic malignancies received the most votes, there were a number of fields that had significant additions to their armamentariums this year.
 
Several oncology experts shared their thoughts on the approvals they found most important in 2018. Tanios Bekaii-Saab, MD, a professor of medicine at the Mayo Clinic, reflected on how far precision medicine has come, while Geoffrey R. Oxnard, MD, an associate professor of medicine at Harvard Medical School and thoracic oncologist at Dana-Farber Cancer Institute, told Targeted Oncology how the latest progress provides hope in the treatment of cancer.

“In 2001, imatinib (Gleevec) was thought to be the opening act for moving towards more precise medicine,” said Bekaii-Saab. “Unfortunately, the search for these silver bullets in cancer, and more specifically gastrointestinal malignancies, has been largely futile except for some rare bright spots….”

“To me, more FDA approvals represents a signal of progress and a source of hope,” Oxnard commented. “Patients with lung cancer need to know there are more treatment options and more clinical trials than ever before. There is no more room for the nihilism of years past when it comes to lung cancer treatment.”
 

Lung Cancer


Osimertinib Approved by FDA as First-Line Treatment for Patients with EGFR+ NSCLC

On April 19, 2018, the FDA approved osimertinib (Tagrisso) as a frontline treatment option for patients with non–small cell lung cancer (NSCLC) with tumors harboring EGFR mutations. Frontline osimertinib reduced the risk of progression or death by 54% in the FLAURA trial compared to standard TKI therapies.

Nivolumab Approved by FDA in Small Cell Lung Cancer

On August 17, 2018, nivolumab (Opdivo) was approved for patients with small cell lung cancer (SCLC) as a monotherapy after disease progression follow a platinum-based chemotherapy and 1 other prior line of therapy. This agent was the first checkpoint inhibitor approved for this specific patient population.
 

Breast Cancer


Olaparib Granted FDA Approval for BRCA+ Breast Cancer

Olaparib (Lynparza), a PARP inhibitor, was approved on January 12, 2018, for the treatment of patients with BRCA-positive, metastatic breast cancer. In findings from the phase III OlympiAD trial, olaparib reduced the risk of disease progression or death by 42% and also improved progression-free survival (PFS) by 2.8 months compared to standard chemotherapy.

"This study is exciting because it demonstrates that evaluating tumor therapies based on associated genetic mutations can be successful," said Deanna J. Attai, MD, FACS, assistant clinical professor in the department of surgery at David Geffen School of Medicine at UCLA. "It's especially encouraging to see some progress being made at least in a subset (BRCA mutation carriers) of patients with triple-negative breast cancer."

Ribociclib Granted Expanded FDA Approval in Breast Cancer

On July 18, 2018, frontline ribociclib (Kisqali) was approved for combination use with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with HR-positive/HER2-negative advanced or metastatic breast cancer. In addition, this CDK4/6 inhibitor was approved by the FDA in combination with fulvestrant for the treatment of postmenopausal women with HR-positive/HER2-negative advanced or metastatic breast cancer, in the frontline setting or after disease progression on endocrine therapy.

"The new indication for ribociclib for use in patients with advanced or metastatic breast cancer gives these patients an additional non-chemotherapy option," Attai commented. "Ribociclib and the other drugs in its class are certainly not free from side effects, but treatments that improve outcomes in patients with advanced and metastatic breast cancer are welcome."
 
 

Hematologic Malignancies


"The 2 main FDA approvals in myeloma in 2018 were the use of carfilzomib once weekly at a dose of 70 mg/m2 in combination with dexamethasone and the approval of elotuzumab in combination with pomalidomide and dexamethasone," said Alexander M. Lesokhin, MD, assistant attending physician in the department of medicine and myeloma service at Memorial Sloan Kettering Cancer Center. "Both of these treatments were evaluated in patients whose myeloma had relapsed following at least 2 therapies inclusive of IMiDs and proteasome inhibitors (PIs)."

Once-Weekly Carfilzomib Regimen Approved by the FDA for Myeloma

On October 1, 2018, carfilzomib (Kyprolis) was approved for use in combination with dexamethasone for patients with relapsed/refractory multiple myeloma.

"Carfilzomib was approved based on the ARROW trial, a phase III trial that showed a PFS benefit of 3.7 months with weekly dosing at 70mg/m2 when compared with 27.mg/m2 given twice weekly," said Lesokhin.

Elotuzumab Triplet Approved by FDA for Treatment of Myeloma

The triplet regimen of elotuzumab (Empliciti) with pomalidomide (Pomalyst) and low-dose dexamethasone (EPd) was approved on November 6, 2018, for the treatment of patients with relapsed/refractory multiple myeloma following 2 or more prior therapies, including lenalidomide (Revlimid) and a PI.

"Elotuzomab with pomalidomide and dexamethasone demonstrated a 10.3 month PFS, which was significantly improved when compared to pomalidomide/dexamethasone in a randomized phase II trial," Lesokhin said.

"These approvals increase both the availability and the convenience of treatment for patients with relapsed myeloma," Lesokhin concluded.

Frontline Venetoclax Granted Accelerated FDA Approval for Older Patients With AML

On November 21, 2018, the FDA approved venetoclax (Venclexta) in combination with azacitidine or decitabine or low-dose cytarabine as a treatment for adult patients with newly diagnosed acute myeloid leukemia (AML) who are aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

Daniel A. Pollyea, MD, MS, associate professor of medicine and clinical director of leukemia services at the University of Colorado School of Medicine, said that this approval “will impact the outcomes of many of these patients in a positive way. We have seen very promising response rates and with early follow up, good response durations, and the fact that this treatment is not a genomically-defined targeted therapy allows it to have a wide impact.”

Ivosidenib Granted FDA Approval for IDH1+ AML

Ivosidenib (Tibsovo) was granted approval by the FDA on July 20, 2018, for the treatment of adult patients with relapsed/refractory IDH1-mutant AML.

Pollyea told Targeted Oncology, “Ivosidenib for IDH1-mutated relapsed AML is also a therapy that is well tolerated and effective for many patients with few alternative treatment options.”
 
 

Other Impactful Approvals


Lenvatinib Gains FDA Approval for Frontline HCC

Lenvatinib (Lenvima) was approved on August 16, 2018 for frontline treatment of patients with hepatocellular carcinoma (HCC). This approval was based on data from the phase III REFLECT trial in which lenvatinib was established as noninferior to the standard of care sorafenib (Nexavar).

Larotrectinib Granted FDA Approval for NTRK+ Cancers

On November 26, 2018, the FDA approved larotrectinib (Vitrakvi) for treatment of adult and pediatric patients with solid tumors with an NTRK gene without a known acquired resistance mechanism, who are metastatic, or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or have already progressed following treatment.

"Responses were observed in 3 out of every 4 patients on the study, including a 22% complete response rate," Bekaii-Saab said. "In GI malignancies, we expect this fusion to be present in less than 0.5% of patients, and routine genomic sequencing is key to finding such a rare event."

In a discussion on this agent in TRK+ thyroid cancers, Marcia S. Brose, MD, PhD, said, “The amazing thing about this drug is there are patients out there who have widely metastatic disease or disease to the point where we honestly expect to end their lives, and within 2 to 3 months of starting this agent, they are now 3 years out.”

"This continues to be an exciting time for our patients with cancer, with the hope to continue to uncover more relevant targets and bring agents similar in their impact to laratrectinib into the clinic," Bekaii-Saab concluded. 

Pembrolizumab Granted FDA Approval for PD-L1+ Cervical Cancer

On June 12, 2018, pembrolizumab (Keytruda) received approval for the treatment of patients with advanced, PD-L1-positive cervical cancer with disease progression on or after chemotherapy.

“Even with the many advances observed across gynecologic cancers, new treatment options have been lacking for previously treated patients with advanced cervical cancer,” Bradley J. Monk, MD, oncologist with Arizona Oncology, medical director of US Oncology Research Gynecology Program, and professor of obstetrics and gynecology at University of Arizona’s College of Medicine and Creighton University School of Medicine, said in a statement.


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