Trastuzumab deruxtecan has previously received SAKIGAKE designation for this second potential indication and will receive an expedited review time of six months. Currently, there are no HER2 directed treatment options approved for patients with HER2 positive metastatic gastric cancer who have progressed after trastuzumab.
“Today’s submission by Daiichi Sankyo brings us closer to bringing trastuzumab deruxtecan to a population of patients with unmet medical need in Japan,” said Wataru Takasaki, PhD, Executive Officer, Head of R&D Division in Japan, Daiichi Sankyo. “If approved, trastuzumab deruxtecan has the potential to meaningfully advance the treatment of patients with HER2 positive metastatic gastric cancer as the first ever antibody drug conjugate approved to treat this type of cancer.”
The Japan sNDA is based on data from the pivotal phase 2 DESTINY-Gastric01 trial and phase 1 trial published in The Lancet Oncology. In DESTINY-Gastric01, patients treated with trastuzumab deruxtecan demonstrated a statistically significant and clinically meaningful improvement in objective response rate (ORR) as assessed by an independent review committee as well as in overall survival (OS) compared to patients treated with investigator’s choice of chemotherapy (irinotecan or paclitaxel monotherapy). The full results of DESTINY-Gastric01 will be presented at the 2020 American Society of Clinical Oncology Annual Meeting.
The overall safety and tolerability profile of trastuzumab deruxtecan in DESTINY-Gastric01 was consistent with that seen in the phase 1 trial in which the most common adverse events (≥30 percent, any grade) were hematologic and gastrointestinal including neutrophil count decrease, anemia, nausea and decreased appetite. There were cases of drug-related interstitial lung disease (ILD) and pneumonitis, the majority of which were grade 1 and 2 with two grade 3 and one grade 4. No ILD-related deaths (grade 5) occurred in patients with gastric cancer in the phase 1 trial or in the DESTINY-Gastric01 trial.
Accelerated approval in the U.S. and approval in Japan under the conditional early approval system were recently received for trastuzumab deruxtecan for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens.
Source: Company Press Release