The FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search (CDER) re­leased a list of the new and re­vised draft guid­ances it plans to re­lease in 2021.

The agen­da, while of­ten­times as­pi­ra­tional, pro­vides in­sights as to what the agency’s drug cen­ter’s new guid­ance pri­or­i­ties are for the com­ing year. How­ev­er, the list does not in­clude draft or re­vised guid­ances the agency plans to fi­nal­ize in 2021.

Many of the planned guid­ances on the list were in­clud­ed in pre­vi­ous years’ agen­das, such as the pro­posed clin­i­cal phar­ma­col­o­gy draft guid­ance “As­sess­ing the Ef­fects of Food on Drugs in INDs or NDAs – Gen­er­al Con­sid­er­a­tions,” and up­dat­ed guid­ance on “Phar­ma­coge­nom­ic Da­ta Sub­mis­sion” and “Phar­ma­co­ki­net­ics in Pa­tients with Im­paired Re­nal Func­tion – Study De­sign, Da­ta Analy­sis and Im­pact on Dos­ing and La­bel­ing.”

In to­tal, there are 105 guid­ances in­clud­ed on the agen­da, 42 of which are new for 2021. The new guid­ances not car­ried over from 2020 are pre­sent­ed in the ta­ble at the bot­tom of the ar­ti­cle. This year there are four new cat­e­gories of draft guid­ances that ap­pear on the agen­da that were not in­clud­ed in 2020: an­i­mal rule, biosim­i­lars, com­pound­ing and phar­ma­col­o­gy/tox­i­col­o­gy.

Some of the no­table new guid­ances in­clude a guid­ance on meet­ing the stan­dard for sub­stan­tial ev­i­dence based on a sin­gle ad­e­quate and well-con­trolled clin­i­cal tri­al plus con­fir­ma­to­ry ev­i­dence and a guid­ance aimed at class-spe­cif­ic rec­om­men­da­tions for biosim­i­lars and in­ter­change­able prod­ucts. Sev­er­al of the guid­ances on the agen­da are aimed at pro­vid­ing rec­om­men­da­tions for in­di­vid­u­al­ized an­ti­sense oligonu­cleotides (ASO), in­clud­ing guid­ance on clin­i­cal rec­om­men­da­tions to sup­port in­ves­ti­ga­tion­al new drug ap­pli­ca­tion (IND) sub­mis­sions, non­clin­i­cal test­ing, and on chem­istry, man­u­fac­tur­ing and con­trols (CMC) con­sid­er­a­tions for the so-called “n of 1” ther­a­pies.

RAPS: First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.