New Medicines

Advanced breast cancer - oral formulation


New formulation

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Feb 22Filed in EU [6].
Nov 21MHRA validate MAA for oral paclitaxel and encequidar for the treatment of advanced breast cancer. The application qualifies for a 150 day assessment following which a decision on approvability of the product will be provided [3].
Nov 21Athenex discontinue development of oral pacilitaxel and encequidar in US, following a recent Type A meeting with the FDA to discuss resubmission of a NDA [2].
Nov 21Encequidar in combination with oral anticancer medicines is awarded innovative medicine designation by MHRA [2].
Mar 21Athenex receives FDA Complete Response Letter for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer. In the CRL, the FDA indicated its concern of safety risk to patients in terms of an increase in neutropenia-related sequelae on the oral vs. IV paclitaxel arm. They also expressed concerns regarding uncertainty over the results of the primary endpoint of objective response rate (ORR) at week 19 conducted by blinded independent central review (BICR). The Agency stated that the BICR reconciliation and re-read process may have introduced unmeasured bias and influence on the BICR [1].


Angiogenesis inhibitor co-formulated with oral absorption enhancer HM 30181A
Approximately 50,000 new cases of breast cancer are diagnosed each year in the UK [4].
Advanced breast cancer - oral formulation

Further information


Trial or other data

Jul 22PIII KX-ORAX-001 study (n=402) found oral paclitaxel with encequidar was associated with higher confirmed tumour response rate than IV paclitaxel (36% v 23%; p=0.01), with a trend towards improved progression-free survival (8.4 v 7.4 months; HR 0.768; 95.5% CI 0.58 to 1.01; P=0.046) [7].
Nov 21 Data from PIII KX-ORAX-001 (NCT02594371) trial (n=402) forms basis of the MAA, which compared safety and efficacy of oral vs. IV paclitaxel monotherapy in patients with metastatic breast cancer. Study achieved its primary endpoint showing statistically significant improvement in overall response rate (ORR), along with a lower incidence of neuropathy, for oral vs. IV paclitaxel [3,5].