With Approvals in Hand, These Three New Drugs Are Hitting the Market

Less than two weeks after receiving the greenlight for Zynlonta under accelerated approval, ADC Therapeutics has launched its treatment for adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).

Switzerland-based ADC announced the commercial launch of Zynlonta during its first quarter earnings report. Ron Squarer, chairman of the ADC Therapeutics Board of Directors, said the company is “executing on its launch plan” for the CD19-targeted antibody-drug conjugate (ADC). Squarer said the company is well-equipped to support the physicians who will administer Zynlonta as they adopt “an important new option with a broad label which included tough to treat patients in third-line plus DLBCL.”

In April, the U.S. Food and Drug Administration granted accelerated approval to Zynlonta as a treatment for adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low grade lymphoma and high-grade B-cell. Like other drugs greenlit under accelerated approval, a confirmatory trial may be required to support the efficacy and safety of the drug. 

Zynlonta’s approval was based on positive data from the Phase II LOTIS-2 trial that showed the drug demonstrated an overall response rate of 48.3%, including a complete response rate of 24.1% and a partial response rate of 24.1%. Patients had a median time to response of 1.3 months, and the median duration of response was 10.3 months.

ADC Therapeutics wasn’t the only company to launch a new drug this quarter. 

In August 2020, Trevena, Inc. won approval for Olinvyk, an intravenous opioid medication for short term management of acute pain in a hospital setting. The drug was not immediately available for use in a clinical setting due to the U.S. Drug Enforcement Agency requirement to issue a controlled substance schedule for the new medication. The drug was finally launched earlier this year. 

In its first quarter report, Trevena said it had deployed a virtual field team at the end of February. Currently, there are more than 60 different records in various stages of reviewing the drug. The company noted that ten accounts had added Olinvyk to its formulary.

“Despite the impact of COVID-19, the company is encouraged by the early progress and reaffirms its year-end goal of 100 formulary approvals,” Trevena said in its announcement.

Olinvyk is an opioid agonist and is the first new chemical entity in this IV drug class approved over the past several decades. Approval of Olinvyk was based on results from a Phase III program that included two pivotal efficacy studies in hard- and soft-tissue surgical models.

North Carolina-based BioCryst also launched a newly-approved drug during the first quarter. In its first quarter announcement, BioCryst said Orladeyo, the first oral prophylaxis approved to prevent hereditary angioedema (HAE) attacks in adults and adolescents, generated $10.9 million in the first quarter. 

The majority of Orladeyo revenue in the first quarter of 2021 came from new patients who switched to the BioCryst drug from either injectable/infused prophylactic medications or acute-only treatment. The remainder came from patients transitioning from clinical trials and the company’s early access program, the company said. 

The company is now seeking the approval of Orladeyo in Europe and other markets. 

“Our commercial team is off to an outstanding start with the U.S. launch of Orladeyo. In this highly competitive market, we are demonstrating what we have known for some time now, HAE patients have been waiting to switch to an oral, once-daily therapy to reduce their attacks and burden of therapy,” Jon Stonehouse, president and chief executive officer of BioCryst said in a statement.